This material should not be considered the exclusive source of information, it does not replace or supersede information contained in the device manual(s). Please note that the intended use of a product may vary depending on geographical approvals. See the device manual(s) for detailed information regarding the intended use, the procedure, indications, contraindications, warnings, precautions, and potential adverse events. Medtronic products placed on markets comply with legislation (if applicable) on medical devices.

If you are located in the United States, please refer to the brief statement(s) below to review applicable indications, safety and warning information. If you are located outside the United States, see the device manual for detailed information. For further information, contact your local Medtronic representative and/or consult the Medtronic website at www.medtronic.com.

Liberant™ thrombectomy system

Reference Statement

Indications for Use:
The Liberant thrombectomy system is indicated for the removal of fresh, soft emboli or thrombi from the vessels of the peripheral arterial and venous systems.

Contraindications
Do not use the Liberant thrombectomy system in the coronary vasculature or neurovasculature. Do not use in patients for whom anticoagulant or antiplatelet therapy is contraindicated.

Potential Adverse Effects of the Device on Health
The potential complications include, but are not limited to the following: allergic reaction to device materials; anemia; death; embolization; hemorrhage; hypotension; infection; inability ischemia or infarction; pain; thrombosis; total occlusion of treated vessel; venous or valvular damage; including arteriovenous fistula, dissection, perforation, pseudoaneurysm, or vascular aneurysm; adverse events associated with endovascular procedures, including acute renal impairment, allergic reaction to contrast medium, cerebrovascular accident, hemorrhage or hematoma at access site, hypertension.

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

Important information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device, or contact a Medtronic representative.

Integrated Risk Statement
Risks include, but are not limited to, embolization, hemorrhage, thrombosis, and vessel damage.

Excipio™* LV Thrombectomy Device
Reference Statement
Indications for Use
The Excipio™* LV thrombectomy device is indicated for the nonsurgical removal of emboli and thrombi from peripheral blood vessels.

Contraindications

  • Not intended for use in the coronary arteries, pulmonary vasculature or neurovasculature.
  • Do not use on patients with known hypersensitivity to nickel-titanium.

Potential Adverse Effects
The potential complications include, but are not limited to the following: access site complications, acute occlusion, allergic reaction, arrhythmia, anemia, death, hematoma or hemorrhage at access site, hemorrhage, hypotension, inability to completely remove thrombus, intimal disruption, ischemia, infection, renal impairment or acute renal failure from contrast media, thromboembolic events, tip separation and distal embolization; vessel spasm, thrombosis, dissection, or perforation.

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

Important information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device, or contact a Medtronic representative.

Excipio™* SV Thrombectomy Device
Reference Statement
Indications for Use
The Excipio™* SV thrombectomy device is indicated for the non-surgical removal of soft emboli and thrombi from peripheral blood vessels.

Contraindications

  • Not intended for use in the coronaries or the neuro-vasculature.
  • Do not use on patients with known hypersensitivity to nickel-titanium.

Potential Adverse Effects
The potential complications include, but are not limited to the following: access site complications, allergic reaction, arterial dissection, arterial thrombosis, death, distal embolization of blood clots and atherosclerotic plaque, hematoma, hemorrhage, ischemia, infection, perforation and/or vessel rupture, tip separation and distal embolization, vasospasm

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

Important information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device, or contact a Medtronic representative.

HawkOne™ directional atherectomy system
Reference Statement
Indications for Use
The HawkOne™ 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.

Contraindications
Do not use in the coronary arteries, carotid artery, or in the iliac, or renal vasculature.
Do not use for in-stent restenosis at the peripheral vascular site.

Potential Adverse Events
The potential complications include, but are not limited to the following: Amputation, aneurysm, arterial dissection, arterial perforation, arterial rupture, arterial spasm, arteriovenous fistula, bleeding complications, death, embolism or arterial thrombosis, emergency or non-emergency arterial bypass surgery, entry site complications, hypotension, infection, ischemia, restenosis of the treated segment, total occlusion of the peripheral artery, and vascular complications that could require surgical repair.

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

Important information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device, at www.medtronic.com/manuals or contact a Medtronic representative.

EverFlex™ self-expanding peripheral stent system
Brief Statement
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.

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.

Warnings

  • If resistance is encountered at any time during the insertion procedure, do not force passage. Forced passage may damage the stent or the vessel. If resistance is felt, carefully withdraw the stent system without deploying the stent.
  • If resistance is felt when initially pulling back on the distal grip, do not force deployment. Carefully withdraw the stent system without deploying the stent.
  • If resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit.

Precautions

  • Do not exceed 20 atm or 300 psi (2068 kPa) while flushing the delivery system.
  • Always use an introducer sheath during the implant procedure to protect the vessel and the puncture site. Support from an introducer sheath is also necessary to minimize lengthening or shortening of the stent during stent deployment.
  • If the lesion is not predilated, it may be difficult to properly position or remove the stent system.
  • The stent system is not designed for recapturing or repositioning after establishing vessel apposition.
  • Failure to hold the proximal grip in a fixed position may result in partial deployment, foreshortening, lengthening, or increased deployment force.
  • The stent is not designed to be lengthened or shortened relative to its nominal length. Excessive stent lengthening or shortening may increase the risk of stent fracture.
  • Use caution when crossing a deployed stent with any adjunct device.
  • Do not expand the stent beyond its nominal diameter.

Potential Adverse Events
The potential complications include, but are not limited to the following: 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, contract 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, psedoaneurysm, 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.

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

Important information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device, at www.medtronic.com/manuals or contact a Medtronic representative.

SpiderFX™ embolic protection device
Reference Statement
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.

Contraindications
Do not use with patients in whom anticoagulant and antiplatelet therapy is contraindicated; Do not use in vessels with excessive tortuosity; Do not use in patients with uncorrected bleeding disorders; Do not use in the renal arteries.

Potential Adverse Events
The potential complications include, but are not limited to the following: Access site adverse event (e.g., av fistula, hematoma, hemorrhage, pseudoaneurysm, puncture site infection); Adjunct device entanglement (LE only); Adverse reaction to antiplatelet/anticoagulation agents or contrast media; Allergic reaction to device materials; Amaurosis Fugax (carotid only); Amputation (LE only); Aneurysm (LE and SVG); Angina (carotid and SVG only); Arterial dissection; Cerebral hemorrhage (Carotid only); Congestive heart failure (carotid only); Cardiac tamponade (SVG only); Coronary ischemia (SVG only); Death; Device(s) deformation, collapse, fracture, or rupture; Device(s) thrombosis (acute and subacute); Dissection (LE and carotid only); Embolization of air, debris, plaque or thrombus (evidenced by slow or no-flow) from mechanical disruption by the intervention resulting in TIA or stroke; Embolization or migration of the interventional device(s); Emergency surgery; Failure to deliver stent to the intended site (SVG only); GI bleeding due to anticoagulation (LE and carotid only); Hemodynamic compromise (e.g., prolonged hypotension requiring treatment with intravenous medications) (LE and carotid only); Hyperperfusion syndrome (carotid only); Hypotension or hypertension; Infection; Intimal flap (SVG only); Intracerebral bleed (carotid only); Ischemia (LE and SVG only); Myocardial infarction; Occlusion (SVG only); Renal insufficiency (LE and carotid only); Renal failure requiring dialysis; Repeat intervention to treatment site (LE only); Restenosis of stented segment (greater than 50% obstruction) (SVG only); Seizure (carotid only); Sepsis; Significant cardiac arrhythmia requiring treatment with medications and/or transvenous pacing; Stent entanglement; Stroke (LE and carotid only); Thrombosis (acute and subacute); Transient Ischemia Attack (TIA) (LE and carotid only); Vasospasm; Vessel dissection, perforation, rupture or intimal flap; Vessel/filter occlusion

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

Important information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device, at www.medtronic.com/manuals or contact a Medtronic representative

IN.PACT™ 018 Paclitaxel-coated percutaneous transluminal angioplasty balloon catheter
Brief Statement
Indications for Use
The IN.PACT™ 018 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 360 mm in superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.

Contraindications

  • The IN.PACT™ 018 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
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™ 018 DCB.
Do not exceed the rated burst pressure (RBP). The RBP is 10 atm (1013 kPa) and 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™ 018 DCBs with a total drug dosage exceeding 34,854 μg of paclitaxel in a patient has not been clinically evaluated.

Precautions

  • Assess risks and benefits before treating patients with a history of severe reaction to contrast agents.
  • Administer appropriate drug therapy to the patient according to standard protocols for PTA before insertion of the dilatation catheter.
  • Take precautions to prevent or reduce clotting when any catheter is used. Flush and rinse all products entering the vascular system with heparinized normal saline or a similar solution. For the IN.PACT™ 018 DCB catheter, flush the guidewire lumen through the guidewire port with heparinized normal saline until the fluid exits the distal tip. Do not rinse or wipe the IN.PACT™ 018 DCB catheter.
  • Identify allergic reactions to contrast media and antiplatelet therapy before treatment and consider alternatives for appropriate management prior to the procedure.
  • This product is not intended for the expansion or delivery of a stent.
  • This product is not intended for pre-dilation or post-dilatation
  • Do not expose the product to organic solvents such as alcohol.
  • To reduce the potential for vessel damage, the inflated diameter of the balloon should approximately match the diameter of the vessel just distal to the lesion.

Potential Adverse Events
The potential adverse events associated with use of the device include but are not limited to: 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, and vessel trauma which requires surgical repair.

Potential adverse events not captured above 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, and peripheral neuropathy. Refer to the Physician’s Desk Reference for more information on the potential adverse effects observed with paclitaxel.

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

Important information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device, at www.medtronic.com/manuals or contact a Medtronic representative.

Abre™ venous self-expanding stent system
Brief Statement
Indications for Use
The Abre™ venous self-expanding stent system is indicated for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.

Contraindications
Do not use the Abre™ stent system with patients with known hypersensitivity to nickel titanium (nitinol), with patients who are judged to have a lesion that prevents complete inflation of a balloon dilatation catheter or proper placement of the stent or the stent delivery system, and with patients in whom anticoagulant or antiplatelet therapy is contraindicated.

Warnings

  • If unusually high resistance is encountered when advancing the Abre delivery system over the guidewire, assess the cause of the resistance before proceeding.
  • If high resistance is felt when initially rotating the thumbwheel, do not force deployment. Carefully withdraw the system and do not use it.
  • Do not use in patients with a total venous occlusion that cannot be dilated to allow passage of the guidewire.
  • Do not use the device with contralateral access.

Precautions

  • Avoid placing the cranial end or caudal end of the stent within the common iliac vein at the transition curve to the external iliac vein and internal iliac confluence. Improper placement of the stent may result in tenting or kinking of the vessel. Extending the stent length beyond the transition curve is recommended to minimize risk of migration. Stent migration can potentially lead to vessel occlusion, thrombus formation, vessel damage, embolism, and/or the need for surgical intervention, including open surgical removal from the heart.
  • Selection of the appropriate stent diameter and length is crucial. An undersized stent can result in stent migration and suboptimal luminal diameter. Stents with a diameter of ≤14 mm and/or lengths of ≤80 mm should be assessed for applicability as a stand-alone stent because of migration risk, particularly in non-thrombotic iliac vein lesions and in patients that have had a previous DVT, but otherwise have normal veins with an iliac vein compression.
  • Ensure that there is appropriate stent apposition to the vessel wall to secure sustained fixation through changing vessel size and shape during the procedure and post-procedural patient movement. Options to ensure appropriate stent apposition include visualization with IVUS during the procedure, confirming that the stent is extended around a curve, that the stent diameter is constrained by the vessel below the stent’s nominal diameter, or that the stent is anchored by a second stent.
  • Always use an introducer sheath during the implant procedure to protect both the vessel and puncture site
  • If the retractable sheath (silver) is exposed beyond the hemostatic valve when the stent is positioned for deployment, pull the introducer sheath back so that the hemostatic valve covers the end of the isolation sheath (blue) and is not in direct contact with the retractable sheath. Friction from direct contact between the retractable sheath and the hemostatic valve can cause difficult stent deployment or inaccurate stent placement.
  • Do not reposition the Abre stent after establishing apposition against the vessel wall. Repositioning the stent may cause stent elongation, stent fracture, or vessel damage.
  • The Abre stent is not designed to be lengthened or shortened from its nominal length. Excessive stent lengthening or shortening can increase the risk of stent fracture.
  • If resistance is felt when withdrawing the system, do not force withdrawal. Forcing withdrawal can cause catheter separation and embolism.
  • Use care when crossing a deployed Abre stent with any adjunct device to avoid stent dislodgement or damage to the adjunct device.

Potential Adverse Events
The potential complications include, but are not limited to the following: access failure, access site infection, allergic reaction to contrast medium or procedure medications; aneurysm; AV fistula; bleeding; bruising; death; device breakage; device maldeployment; edema; embolization; fever; hematoma; hypertension; hypotension, nausea, or other vasovagal response; infection; myocardial infarction, arrhythmia, or other cardiovascular insufficiency; open surgical repair; pain; pseudoaneurysm; renal insufficiency or renal failure (new or worsening); respiratory distress or pulmonary embolism; sepsis; stent fracture; stent malapposition; stent malposition; stent migration; stroke, paradoxical embolism, transient ischemic attack, or intracerebral hemorrhage; tissue necrosis; venous occlusion, restenosis, or thrombosis, within or outside of stented segment; and vessel damage, including intimal injury, dissection, perforation, or rupture.

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

Important information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device, at www.medtronic.com/manuals or contact a Medtronic representative.