Important Safety Information

This therapy is not for everyone. Please consult your physician. A prescription is required. For more information, please call Medtronic at (800) 961-9055 . Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions. This content is available electronically at www.manuals.medtronic.com


 

Admiral Xtreme

Reference Statement

Important Information: Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions.

Indications for Use: The Admiral Xtreme™ PTA Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

Test data is on file at Medtronic Inc.
Bench test results may not be indicative of clinical performance.

FTSOP113326-12 Rev. 1A

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Amphirion Deep

Reference Statement

Important Information: Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions.

Indications for Use: The Amphirion™ Deep PTA Balloon Dilatation Catheter up to 120 mm balloon length is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Amphirion Deep PTA Balloon Dilatation Catheter in 150 mm and 210 mm balloon lengths is intended to dilate stenosis in the femoral, popliteal, and infra-popliteal arteries.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

Test data is on file at Medtronic Inc.
Bench test results may not be indicative of clinical performance.

FTSOP113326-13 Rev. 1A

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Amphirion Plus

Reference Statement

Important Information: Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions.

Indications for Use: The Amphirion™ Plus PTA Catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal arteries; and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

Test data is on file at Medtronic Inc.
Bench test results may not be indicative of clinical performance.

FTSOP113326-14 Rev. 1A

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Amplatz™ Goose Neck microsnare kits

Reference Statement

Important Information: Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The Amplatz Goose Neck microsnare kit is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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Amplatz™ Goose Neck snare

Reference Statement

Important Information: Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The Amplatz Goose Neck snare is intended for use in the cardiovascular system or hollow viscus to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access venipuncture procedure assistance.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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Assurant Cobalt

Brief Statement

Indications: The Assurant Cobalt Iliac Balloon-Expandable Stent System is indicated for improving iliac luminal diameter in patients with de novo and restenotic lesions in the common and external iliac arteries with reference vessel diameters between 6 mm and 10 mm and lesion lengths up to 61 mm. The stent is intended as a permanent implant.

Contraindications: There are no known contraindications.

Warnings and Precautions: 

  • The Assurant Cobalt Iliac Balloon-Expandable Stent System is provided sterile for single use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the mechanical/structural integrity of the device, compromise the essential material and design characteristics of the device, and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.
  • Do not modify the packaging or labeling as this may lead to the use of an incorrect or expired product, which could result in patient injury or death. Use prior to the Use By date noted on the package.
  • Patients allergic to cobalt-chromium alloy may suffer an allergic reaction to this implant.
  • Administration of appropriate anticoagulant therapy and/or antiplatelet therapy is critical to the success of the procedure.
  • When multiple stents are required and placement may result in overlap or stent to stent contact, stent materials should be of similar composition to avoid the potential for dissimilar metal corrosion.
  • Use only appropriate balloon-inflation media. Do not use air or gas to inflate the balloon as it may cause uneven expansion and stent deployment difficulties.
  • Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. The long-term outcome following repeat dilatation of endothelialized iliac stents is unknown at present. 

Caution: Read all the instructions carefully in the Instructions for Use. Failure to properly follow the instructions, warnings, and precautions may lead to serious consequences or injury to the patient.

  • Use of the Assurant Cobalt Iliac Balloon-Expandable Stent System requires advanced iliac angioplasty technical skills. The following instructions will provide technical guidance but do not obviate the need for adequate training prior to use of the device.
  • Stent placement should only be performed at hospitals where emergency surgery can be performed.
  • Do not prepare or preinflate the stent delivery balloon prior to stent deployment other than as directed in these Instructions for Use.
  • If the position of the stent is not optimal or appropriate for the vessel, it should not be deployed. The stent cannot be repositioned once deployed.
  • Prior to stent deployment, utilize high resolution fluoroscopy to verify that the stent has not been damaged or dislodged during positioning.
  • The Assurant Cobalt Iliac Balloon-Expandable Stent System is designed for use as a unit. The stent must not be removed from the delivery system.
  • The Assurant Cobalt stent is not designed to be crimped onto another delivery system.
  • Special care must be taken not to handle or in any way disrupt the stent position on the delivery system balloon. Removing the stent from its delivery system or excessively manipulating the stent (eg, rolling the mounted stent) may cause dislodgement, damage to the stent, and stent embolization.
  • Once deployment is initiated, the stent cannot be removed.
  • Prior to completion of the procedure, utilize fluoroscopy to ensure proper positioning of the deployed stent. If the target lesion is not completely stented, use additional Assurant Cobalt Iliac stents as necessary to adequately treat the lesion.
  • Use caution when crossing the stented area with ancillary equipment to avoid dislodgment of the stent.
  • Judicious selection of patients is necessary since the use of this device carries the associated risk of subacute thrombosis, vascular complications, and bleeding events.
  • The Assurant Cobalt Iliac Balloon-Expandable Stent System does not provide for distal contrast injections or pressure measurements through the guidewire lumen.
  • Stent retrieval methods (use of additional wires, snares, or forceps) may result in additional trauma to the vascular access site. Complications may include bleeding, hematoma, or pseudoaneurysm. 

MRI Safety and Compatibility: The Assurant Cobalt Iliac stent was determined to be MR conditional. It can be scanned safely in both 1.5T & 3.0T MR systems under certain conditions as described in the product Instructions for Use. For additional information regarding MR conditions of use, please refer to the product Instructions for Use.

Adverse Events: Potential adverse events include (not arranged in any particular order): acute myocardial infarction, allergic reaction, aneurysm, pseudoaneurysm, arteriovenous fistula, angina, arrhythmias, bleeding complications, death, detachment and/or implantation of a component of the system, embolization, emergent or urgent surgery, fever, hematoma or hemorrhagic event, hypotension or hypertension, infection, ischemia, pain at catheter insertion site, pulmonary embolism, renal failure, restenosis, stent malapposition or migration, stent fracture, stent thrombosis, stroke (CVA or TIA), limb loss, vessel dissection, vascular thrombosis or occlusion at puncture site, treatment site, or remote site, vessel spasm, worsening claudication or rest pain.

Please reference product Instructions for Use for more information regarding all adverse events.

Caution: Federal law (USA) restricts this device for sale by or on order of a physician.

FTSOP113326-07 Rev. 1A

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Babywire™ Guidewire

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The Babywire™ Guidewire is intended for assisting in the placement of initial catheters and/or exchange in the small vessel anatomy. The Babywire Guidewire is compatible with a 24 gauge needle or 2.0 French catheter.

The Babywire Guidewire is not indicated for coronary use.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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BigEasy™ Rotating Y-connectors

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The BigEasy™ Rotating Y-connectors is designed for use during Percutaneous Transluminal Coronary Angioplasty (PTCA) and other intervascular therapeutic procedures that utilize a guiding catheter. The Y-connector provides a means for inserting guidewires or catheters into the vasculature, and positioning and locking them into place. Turning the thumb wheel prevents blood loss and catheter movement.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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Complete™ SE

Brief Statement

Indications for Use

Complete SE used in the Iliac artery
The Medtronic Vascular Complete™ SE Vascular Stent System is indicated for improving luminal diameter in patients with iliac stenosis in previously unstented lesions with vessel reference diameters between 4.5 mm and 9.5 mm and lesion lengths up to 110 mm. The stent is intended as a permanent implant.

Complete SE used in the Superficial Femoral/Proximal Popliteal arteries The Complete SE Vascular Stent System is indicated to improve luminal diameter in symptomatic patients with de novo and/or restenotic lesions or occlusions of the superficial femoral artery (SFA) or proximal popliteal artery (PPA) with reference diameters ranging from 4 mm and 7 mm and lesion lengths up to 140 mm.

Contraindications: The Complete SE Vascular Stent System is contraindicated in:

  • patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system
  • patients who cannot receive a recommended antiplatelet or anticoagulation therapy

Warnings and Precautions: The Complete SE Vascular Stent System should only be used by physicians and medical personnel trained in vascular interventional techniques (including advanced iliac artery or SFA angioplasty or stenting techniques) and trained on the use of this device. Specific training expectations are described in the Physician Training Requirements of the device's Instructions for Use.

The Complete SE Vascular Stent System is provided sterile for one procedure only. Do not re-sterilize. Use prior to the "Use By" date noted on the package. Do not use if the temperature indicator found on the inner pouch is changed from a gray square to a black square as this indicates the unconstrained stent diameter and stent release may be compromised. Do not deploy the stent if it is not optimal or appropriate for the vessel. Prior to stent deployment, utilize fluoroscopy to verify the stent has not been damaged or dislodged during positioning. Prior to completion of the procedure, utilize fluoroscopy to ensure proper positioning of the deployed stent. If the target lesion is not completely stented, use additional Complete SE Vascular Stents as necessary to adequately treat the lesion. If your patient cannot be adequately anticoagulated, it is unknown whether thrombus formation may occur with this product. The use of overlapping stents with the Complete SE Vascular Stent System has not been formally evaluated in a clinical trial; overlap stents have been evaluated on the bench/Finite Element Analysis (FEA) and results are on file at Medtronic. Caution must be taken when crossing the stented area with ancillary equipment to avoid dislodgment of the stent.

MRI Safety and Compatibility: The Complete SE Vascular Stent System is MR Conditional. It can be scanned safely in both 1.5 T and 3 T whole-body-cylindrical MR systems under certain conditions as described in the product Instructions for Use. For additional information regarding MRI, please refer to the Instructions for Use. For additional information regarding MRI, please refer to the Instructions for Use.

Potential Adverse Events: Adverse events that may occur or require intervention include, but are not limited to the following: abrupt stent closure, allergic reaction (contrast medium; drug; stent or filter material), amputation or limb loss, aneurysm or pseudoaneurysm (in vessel or at vascular access site), angina or coronary ischemia, arrhythmia (including premature beats, bradycardia, atrial or ventricular tachycardia, atrial or ventricular fibrillation[VF]), asystole or bradycardia (requiring placement of a temporary pacemaker), arteriovenous fistula, bleeding complications from anticoagulant or antiplatelet medication requiring transfusion or surgical intervention, death, detachment of a system component or implantation in an unintended site, emboli, distal (for example, air, tissue, plaque, thrombotic material or stent), emergent bypass surgery to perfuse limb, fever, hematoma at vascular access site (with or without surgical repair), hypotension or hypertension, infection, local or systemic (including bacteraemia or septicemia), ischemia requiring intervention (bypass or amputation of toe, foot, or leg), myocardial infarction, occlusion of iliac artery, SFA /PPA, or distal vasculature, pain (leg or foot), pain at catheter insertion site, pulmonary embolism, renal failure or insufficiency (secondary to contrast medium), restenosis of vessel in stented segment, stent malposition or migration (which may require emergency surgery to remove stent), stent strut fracture, stent thrombosis or occlusion, stroke, vascular thrombosis or occlusion (at puncture site, treatment site, or remote site), vessel dissection, perforation or rupture, vessel spasm or recoil.

Please reference appropriate product Instructions for Use for a detailed list of indications, warnings, precautions and potential adverse events. This content is available electronically at www.manuals.medtronic.com

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

FTSOP113326-20 Rev. 1D

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Cragg-McNamara™ valved infusion catheters

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The Cragg-McNamara™ Micro Therapeutics Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents or radiopaque contrast media into the general vasculature. All pharmacologic agents utilized with the Micro Therapeutics Infusion Catheter should be fully prepared and used according to the instructions for use of the specific pharmacologic agent. The Micro Therapeutics Infusion Catheter is not intended for coronary, pediatric or neonatal use.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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Enteer™ Re-Entry System


 

Enteer™ Re-entry Catheter

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The Enteer™ Re-entry Catheter is indicated for directing, steering, controlling and supporting a guidewire in order to access discrete regions of the peripheral vasculature. When used as part of the Peripheral System, the Enteer Catheter is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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Enteer™ Re-entry Guidewire

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The Enteer™ Re-entry Guidewire is intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal angioplasty (PTA). The Enteer Guidewire is not to be used in cerebral blood vessels. When used as part of the Peripheral System, the Enteer Guidewire is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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Directional Atherectomy


 

HawkOne™ Directional Atherectomy System

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The HawkOne™ peripheral directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX embolic protection device in the treatment of severely calcified lesions. The HawkOne catheter is NOT intended for use in the coronary, carotid, iliac or renal vasculature.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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SilverHawk™ Plaque Excision System

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The SilverHawk™ Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The catheter is NOT intended for use in the coronary, carotid, iliac or renal vasculature.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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TurboHawk™ Plaque Excision System

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The TurboHawk™ Peripheral Plaque Excision System is intended for use in the atherectomy of the peripheral vasculature. The TurboHawk catheter is NOT intended for use in the coronary, carotid, iliac, or renal vasculature.

The TurboHawk Catheter is indicated for use in conjunction with the SpiderFX™ Embolic Protection Device in the treatment of severely calcified lesions (LS-C and LX-C only).

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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EverCross™ 0.035 PTA Balloon Catheter

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The EverCross™ 0.035” OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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EverFlex™ Self-Expanding Stent System

Brief Statement

Indication: The EverFlex™ Self-Expanding Peripheral Stent System is intended to improve luminal diameter in the treatment of symptomatic denovo or restenotic lesions up to 180 mm in length in the native superficial femoral artery and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 mm – 7.5 mm.

The EverFlex Self-Expanding Peripheral Stent System is indicated for improving luminal diameter in patients with atherosclerotic disease of the common and/or external iliac arteries up to and including 100 mm in length, with a reference vessel diameter of 4.5 mm - 7.5 mm.

The Protégé EverFlex Self-expanding Biliary Stent System is intended as a palliative treatment of malignant neoplasms in the biliary tree.

Contraindications: Use of the EverFlex™ Self-Expanding Peripheral Stent System is contraindicated in patients with known hypersensitivity to nickel titanium and in patients contraindicated for anticoagulant and/or antiplatelet therapy, patients who are judged to have a lesion that prevents complete inflation an angioplasty balloon or proper placement of the stent or stent delivery system.

Potential Adverse Events: Potential adverse events which may be associated with the use of a stent in the SFA and proximal popliteal arteries include, but are not limited to:  Allergic reaction, Amputation, Artery perforation or rupture, Bleeding requiring transfusion, Infection, Pseudoaneurysm, Restenosis, Stent collapse or fracture, Stent migration, Surgical or endovascular intervention, Thrombosis/occlusion of the stent.

See the Instructions for Use provided with the product for a complete list of warnings, precautions, adverse events and device information.

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.

DC0037736 Rev.A

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EverFlex™ Self-expanding Peripheral Stent with Entrust™ Delivery System

Brief Statement

Indication: The EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 mm - 7.5 mm.

Contraindications: Use of the EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery System is contraindicated in patients with known hypersensitivity to nickel titanium; patients contraindicated for anticoagulant and/or antiplatelet therapy; patients who have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system. The EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery System is contraindicated for use in the carotid artery.

Potential Adverse Events: Potential adverse events which may be associated with the use of a stent in the SFA and proximal popliteal arteries include, but are not limited to:  Allergic reaction, Amputation, Artery perforation or rupture, Bleeding requiring transfusion, Infection, Pseudoaneurysm, Restenosis, Stent collapse or fracture, Stent migration, Surgical or endovascular intervention, Thrombosis/occlusion of the stent.

See the Instructions for Use provided with the product for a complete list of warnings, precaution, adverse events and device information.

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.

DC0037737 Rev.A

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FiberNet

Reference Statement

Important Information: Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, suggested procedure, warnings and precautions.

Indications for Use: The FiberNet™ Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm.

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.


Test data is on file at Medtronic Inc.
Bench Test results may not be indicative of clinical performance.

FTSOP113326-15 Rev. 1A 

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Fortrex™ 0.035 OTW PTA Balloon Catheter

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The Fortrex™ 0.035” OTW PTA balloon catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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IN.PACT™ Admiral™ Paclitaxel-Coated PTA Balloon

Brief Statement

Indications For Use: The IN.PACT™ Admiral™ Paclitaxel-Coated PTA Balloon catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.

Contraindications: The IN.PACT Admiral DCB is contraindicated for use in:

  • Coronary arteries, renal arteries, and supra-aortic/cerebrovascular arteries
  • Patients who cannot receive recommended antiplatelet and/or anticoagulant therapy
  • Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system
  • Patients with known allergies or sensitivities to paclitaxel
  • Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to father children. It is unknown whether paclitaxel will be excreted in human milk and whether there is a potential for adverse reaction in nursing infants from paclitaxel exposure.

Warnings

  • Use the product prior to the Use-by Date specified on the package.
  • Contents are supplied sterile. Do not use the product if the inner packaging is damaged or opened.
  • Do not use air or any gaseous medium to inflate the balloon. Use only the recommended inflation medium (equal parts contrast medium and saline solution).
  • Do not move the guidewire during inflation of the IN.PACT Admiral DCB.
  • Do not exceed the rated burst pressure (RBP). The RBP (14 atm [1419 kPa]) is based on the results of in vitro testing. Use of pressures higher than RBP may result in a ruptured balloon with possible intimal damage and dissection.
  • The safety and effectiveness of implanting multiple IN.PACT Admiral DCBs with a total drug dosage exceeding 20,691 µg of paclitaxel in a patient has not been clinically evaluated in the IN.PACT SFA Trial.

Precautions

  • This product should only be used by physicians trained in percutaneous transluminal angioplasty (PTA).
  • This product is designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.
  • Assess risks and benefits before treating patients with a history of severe reaction to contrast agents.
  • The safety and effectiveness of the IN.PACT Admiral DCB used in conjunction with other drug-eluting stents or drug-coated balloons in the same procedure or following treatment failure has not been evaluated.
  • The extent of the patient’s exposure to the drug coating is directly related to the number of balloons used. Refer to the Instructions for Use (IFU) for details regarding the use of multiple balloons and paclitaxel content.
  • The use of this product carries the risks associated with percutaneous transluminal angioplasty, including thrombosis, vascular complications, and/or bleeding events
  • Vessel preparation using only pre-dilatation was studied in the clinical study. Other methods of vessel preparation, such as atherectomy, have not been studied clinically with IN.PACT Admiral DCB.

Potential Adverse Events: Adverse events that may occur or require intervention include, but are not limited to the following: abrupt vessel closure; access site pain; allergic reaction to contrast medium, antiplatelet therapy, or catheter system components (materials, drugs, and excipients); amputation/loss of limb; arrhythmias; arterial aneurysm; arterial thrombosis; arteriovenous (AV) fistula; death; dissection; embolization; fever; hematoma; hemorrhage; hypotension/hypertension; inflammation; ischemia or infarction of tissue/organ; local infection at access site; local or distal embolic events; perforation or rupture of the artery; pseudoaneurysm; renal insufficiency or failure; restenosis of the dilated artery; sepsis or systemic infection; shock; stroke; systemic embolization; vessel spasms or recoil; vessel trauma which requires surgical repair.

Potential complications of peripheral balloon catheterization include, but are not limited to the following: balloon rupture; detachment of a component of the balloon and/or catheter system; failure of the balloon to perform as intended; failure to cross the lesion.

Although systemic effects are not anticipated, potential adverse events that may be unique to the paclitaxel drug coating include, but are not limited to: allergic/immunologic reaction; alopecia; anemia; gastrointestinal symptoms; hematologic dyscrasia (including leucopenia, neutropenia, thrombocytopenia); hepatic enzyme changes; histologic changes in vessel wall, including inflammation, cellular damage, or necrosis; myalgia/arthralgia; myelosuppression; peripheral neuropathy.

Refer to the Physician’s Desk Reference for more information on the potential adverse events observed with paclitaxel. There may be other potential adverse events that are unforeseen at this time.

Please reference appropriate product Instructions for Use for a detailed list of indications, warnings, precautions and potential adverse events. This content is available electronically at www.manuals.medtronic.com.

CAUTION: Federal law (USA) rrestricts this device to sale by or on the order of a physician.

FTSOP113326-32 Rev. 1D

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IntraStent™ Biliary Stent System

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.

WARNING: The safety and effectiveness of this device for use in the vascular system have not been established.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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MicroMewi™ Infusion Catheter

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The Micro Therapeutics Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents or radiopaque contrast media into the general vasculature. All pharmacologic agents utilized with the Micro Therapeutics Infusion Catheter should be fully prepared and used according to the instructions for use of the specific pharmacologic agent. The Micro Therapeutics Infusion Catheter is not intended for coronary, pediatric or neonatal use.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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Mo.Ma Ultra

Reference Statement

Important Information: Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, suggested procedure, warnings and precautions.

Indications for Use: The Mo.Ma™ Ultra Proximal Cerebral Protection Device is indicated as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures involving lesions of the internal carotid artery and/or the carotid bifurcation.

The reference diameter of the external carotid artery should be between 3-6 mm and the reference diameter of the common carotid artery should be between 5-13 mm.

Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician.

Test data is on file at Medtronic Inc.
Bench test results may not be indicative of clinical performance.

FTSOP113326-16 Rev. 1A

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NanoCross™ Elite 0.014 PTA Balloon Catheter

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The NanoCross™ Elite 0.014” Over-the-Wire PTA Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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Nitrex™ Nitonol Guidewire

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The 0.014 in. (0.36 mm) and 0.018 in. (0.46 mm) diameter NITREX Nitinol Guidewires are intended for use in the peripheral and coronary vasculature.

The 0.025 in. (0.64 mm) and 0.035 in. (0.89 mm) diameter NITREX Nitinol Guidewires are indicated for use in the peripheral vasculature.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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Pacific Plus

Reference Statement

The Pacific™ Plus PTA Catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal arteries; and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Warning: Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions.

Warning: Do not exceed the rated burst pressure.

Caution: Larger models of the Pacific™ Plus PTA catheter may exhibit slower deflation times, particularly on long catheter shafts.

Potential Adverse Events: Possible adverse events associated with use of the Pacific™ Plus PTA Catheter include, but are not limited to, complications related to puncture such as, but not limited to, local hematoma, infection and hemorrhage; dilatation related complications including, but not limited to, dissection, perforation and restenosis; angiography related complications such as, but not limited to, hypotension, drug/allergic reactions and death.

Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician.

Test data is on file at Medtronic Inc.
Bench test results may not be indicative of clinical performance.

FTSOP113326-09 Rev. 1A

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Pacific Xtreme

Reference Statement

Important Information: Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions.

Indications for Use: The PACIFIC XTREME™ PTA Balloon Dilatation Catheter in 150 mm, 200 mm, 250 mm and 300 mm balloon length is intended to dilate stenoses in femoral, popliteal and infrapopliteal arteries.

Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician.

Test data is on file at Medtronic Inc.
Bench test results may not be indicative of clinical performance.

FTSOP113326-17 Rev. 1A

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ParaMount™ Mini GPS™ Balloon-expandable biliary stent system

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.

WARNING: The safety and effectiveness of this device for use in the vascular system have not been established.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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PowerCross™ OTW PTA balloon catheter

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The PowerCross™ .018” OTW PTA Dilatation Catheter is intended to dilate the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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Prostream™ Infusion Wires

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The ProStream™ Multiple Sidehole Infusion Wire is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents or radiopaque contrast media into the general vasculature. All pharmacologic agents utilized with the ProStream Multiple Sidehole Infusion Wire should be fully prepared and used according to the instructions for use of the specific pharmacologic agent. The ProStream Multiple Sidehole Infusion Wire is not intended for coronary or neurovascular use.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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Protégé™ GPS™ Self-expanding Peripheral and Biliary Stent System

Brief Statement

Indication: The Protégé™ GPS™ Self-Expanding Peripheral Stent Systems is indicated for improving luminal diameter in patients with atherosclerotic disease of the common and/or external iliac arteries up to and including 100 mm in length, with reference vessel diameters of 7.5 – 11 mm.

The stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.

Contraindications: Use of the Protégé™ GPS™ Self-Expanding Peripheral Stent System is contraindicated in patients with known hypersensitivity to nickel titanium; patients contraindicated for anticoagulant and/or antiplatelet therapy; patients who have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system.

Potential Adverse Events: Potential adverse events which may be associated with the use of a stent in the common and/or external iliac arteries include, but are not limited to: Abrupt or sub-acute closure, Allergic reaction to device materials or procedure medications, Allergic reaction to Nitinol, Amputation, Aneurysm, Angina, Arrhythmia, Arterio-venous fistula, Artery injury (e.g., dissection, perforation, or rupture), Bleeding requiring transfusion, Bruising, Contrast medium reaction/renal Failure, Death, Device breakage, Edema, Embolism, Failure to deploy stent, Fever, Gastrointestinal bleeding due to Anticoagulation, Hematoma, Hypertension/Hypotension,Infection,Inflammation,Intraluminal thrombus, Myocardial infarction Pain, Partial stent deployment, Pseudoaneurysm, Renal failure, Renal insufficiency, Restenosis, Sepsis, Shock, Stent collapse or fracture, Stent migration, Stent misplacement, Stroke, Surgical or endovascular Intervention, Thrombosis/occlusion of the stent, Transient ischemic attack, Venous thromboembolism, Vessel spasm, Worsening claudication or rest, pain.

See the Instructions for Use provided with the product for a complete list of warnings, precaution, adverse events and device information.

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.

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Protégé™ RX Self-expanding Carotid Stent System

Brief Statement

Indications: The Protégé™ RX Carotid Stent System, when used in conjunction with the Covidien embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet the following criteria: 1. Patients with carotid artery stenosis (≥ 50% for symptomatic patients by ultrasound or angiography or ≥ 80% for asymptomatic patients by ultrasound or angiography) of the Common or Internal Carotid Artery, AND 2. Patients must have a reference vessel diameter within the range of 4.5 mm and 9.5 mm at the target lesion.

Contraindications: Use of the Protégé RX Carotid Stent System is contraindicated under these circumstances: Patients in whom anticoagulant, antiplatelet therapy or thrombolytic drugs is contraindicated; patients with vascular tortuosity or anatomy, which precludes the safe introduction of the sheath, guide catheter, embolic protection system, or stent system; patients with known hypersensitivity to nickel-titanium; patients with uncorrected bleeding disorders; lesions in the ostium of the common carotid artery.

WARNING: Only physicians who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with carotid interventional procedures should use this device

Potential Adverse Events: Potential adverse events which may be associated with the use of a stent in the common and/or external iliac arteries include, but are not limited to: Abrupt closure, Allergic reactions to procedural medications, contrast dye or device materials, Amaurosis fugax, Aneurysm, Angina/coronary ischemia, Arrhythmia, Arterial occlusion or thrombosis at puncture site or remote site, Arteriovenous fistula, Bacteremia or septicemia, Bleeding from anticoagulant or antiplatelet medications, Bleeding, with or without transfusion, Cerebral edema, Cerebral hemorrhage, Cerebral ischemia or transient ischemic attack (TIA), Congestive heart failure (CHF), Death, Detachment of a component of the device system, Embolism (air, tissue, thrombus), Emergent or urgent endarterectomy surgery (CEA), Fever, Filter thrombosis or occlusion, Fluid overload, Groin hematoma, with or without surgical repair, Hemorrhage, with or without transfusion, Hyperperfusion syndrome, Hypotension or hypertension. Infection and/or pain at the puncture site, Ischemia or infarction of tissue/organ, Myocardial infarction (MI), Pain (head, neck), Pseudoaneurysm, femoral, Renal failure/insufficiency (new or worsening), Restenosis of stented segment, Seizure, Severe unilateral headache, Slow/no flow during procedure, Stent/filter collapse or fracture, Stent/filter entanglement or damage, Stent/filter failure to deploy, Stent embolization, migration or misplacement, Stent or vessel thrombosis/occlusion, Stroke/cerebrovascular accident (CVA), Total occlusion of carotid artery, Vessel dissection, flap, perforation, or rupture,Vessel spasm or recoil.

See the Instructions for Use provided with the product for a complete list of warnings, precaution, adverse events and device information.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

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RapidCross™ OTW PTA Balloon Catheter

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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Rebar™ Reinforced 18” micro catheters

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The Rebar™ Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media. Introducer sheaths are intended for the percutaneous introduction of temporary pacing leads or catheters into the vasculature. The device is not intended for coronary, pediatric or neonatal use.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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Reef HP

Reference Statement

Important Information: Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions.

Indications for Use: The REEF HP™ PTA balloon catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

Test data is on file at Medtronic Inc.
Bench test results may not be indicative of clinical performance.

FTSOP113326-18 Rev. 1A

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Sequel™ Rotating Double Y-connector

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The Sequel™ Rotating Y-connector is designed for use during Percutaneous Transluminal Coronary Angioplasty (PTCA) and other intervascular therapeutic procedures that utilize a guiding catheter. The Y-connector provides a means for inserting guidewires or catheters into the vasculature, and positioning and locking them into place. Turning the thumb wheel prevents blood loss and catheter movement.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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SpiderFX™ Embolic Protection Device

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: Lower Extremity (LE) Interventions
The SpiderFX™ Embolic Protection Device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material in conjunction with the TurboHawk™ Peripheral Plaque Excision System, either during standalone procedures or together with PTA and/or stenting, in the treatment of severely calcified lesions in arteries of the lower extremities. The vessel diameter at the filter basket placement site should be between 3.0 mm and 6.0 mm.

Carotid Interventions
The SpiderFX Embolic Protection Device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.0mm and 7.0mm.

Saphenous Vein Graft (SVG) Interventions
The SpiderFX Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0mm to 6.0mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral vasculature.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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TOTAL across™ Crossing Support Catheter

Reference Statement

Indications for Use: The TOTAL across™ crossing support catheter is intended to guide and support a guidewire during the access of peripheral arteries, allow for wire exchanges, and provide a conduit for the infusion of saline solutions or diagnostic contrast agents.

Warning: Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions.

Potential Adverse Events: Possible adverse events associated with use of the TOTAL across™ crossing support catheter include, but are not limited to, complications related to puncture such as, but not limited to, local hematoma, infection and hemorrhage; procedure related complications including, but not limited to, dissection and perforation; angiography related complications such as, but not limited to, hypotension, drug/contrast medium allergic reactions and death.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

Test data is on file at Medtronic Inc.
Bench test results may not be indicative of clinical performance.

FTSOP113326-21 Rev. 1A

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Trailblazer™ Support Catheter

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: TrailBlazer™ Support Catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. TrailBlazer™ Support Catheters are intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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Viance™ Crossing Catheter

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The Viance™ Catheter is intended for use with a guidewire to access discrete regions of the peripheral vasculature. When used as part of the Peripheral System, the Viance Catheter is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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Visi-Pro™ Balloon-expanding Stent System

Reference Statement

Indications: The Visi-Pro™ Balloon-expandable Peripheral Stent System is indicated for improving luminal diameter in patients with atherosclerotic disease of the common and/or external iliac arteries up to 100 mm in length, with a reference vessel diameter of 5 to 10 mm.

The Visi-Pro™ Balloon-expandable Biliary Stent System is intended as a palliative treatment of malignant neoplasms in the biliary tree.

Contraindications: Use of the Visi-Pro™ Balloon-expandable Peripheral Stent System is contraindicated in patients with known hypersensitivity to stainless steel or its components; patients contraindicated for anticoagulant and/or antiplatelet therapy; patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site; perforation at the angioplasty site; aneurysm of the artery to be treated.

Potential Adverse Events: Potential adverse events which may be associated with the use of a stent in the Iliac arteries include, but are not limited to: Abrupt or sub-acute closure , Allergic reaction to 316L stainless steel , Allergic reaction to device materials or procedure medications , Amputation , Aneurysm , Angina , Arrhythmia , Arterio-venous fistula , Artery injury (e.g., dissection, perforation or rupture) , Bleeding requiring transfusion , Contrast medium reaction/renal failure , Death , Device breakage, Embolism, Failure to deploy stent, Fever, Gastrointestinal bleeding due to anticoagulation, Hematoma, Hypertension/Hypotension, Infection, Inflammation , Intraluminal thrombus , Myocardial infarction , Pain, Partial stent deployment, Pseudoaneurysm, Renal insufficiency, Restenosis, Sepsis, Shock, Stent collapse or fracture, Stent migration, Stent misplacement, Stroke, Surgical or endovascular intervention,Thrombosis/occlusion of the stent, Transient increase in glomerular filtration rate, Transient ischemic attack, Venous thromboembolism, Vessel spasm, Worsening claudication or rest pain.

See the Instructions for Use provided with the product for a complete list of warnings, precaution, adverse events and device information.

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.

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Wholey™ Guidewire

Reference Statement

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The Wholey™ guidewire system is intended to facilitate the placement and exchange of interventional devices during diagnostic or therapeutic interventional procedures. The guidewire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

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