Peripheral Arterial Disease (PAD)

Important Safety Information

Peripheral Arterial Disease (PAD)

IN.PACT Admiral Paclitaxel-Coated PTA Balloon

Brief Statement

The IN.PACT™ Admiral™ Paclitaxel-Coated PTA Balloon catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions with lengths up to 180 mm in 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 using 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.
  • This product is not intended for the expansion or delivery of a stent.

Potential Adverse Effects: The potential adverse effects (e.g. complications) associated with the use of the device are: 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 effects observed with paclitaxel. There may be other potential adverse effects 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 (USA) law restricts the use of this device to sale by or on the order of a physician.

FTSOP113326-32 Rev. 1E

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Complete SE Vascular Stent System

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/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.

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 the use of this device to sale by or on the order of a physician.

FTSOP113326-20 Rev. 1C

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Assurant Cobalt Iliac Balloon Expandable Stent System

Indications For Use

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 6mm and 10mm and lesion lengths up to 61mm. 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.

Rx only 

FDA approved by PMA110011.

FTSOP113326-07 Rev. 1A

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