Aortic Therapies

If you are located in the United States, please refer to the brief statement(s)/reference statement(s) below to review applicable indications, safety and warning information. See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1.763.514.4000 and/or consult the Medtronic website at www.medtronic.com.

If you are located outside the United States, see the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at www.medtronic.com.

Medtronic.com/Manuals

BRIEF STATEMENT: VALIANT™ THORACIC STENT GRAFT SYSTEM

Indications

The Valiant^™Thoracic Stent Graft with the Captivia^™ Delivery System is indicated for the endovascular repair of all lesions of the descending thoracic aorta (DTA) in patients having appropriate anatomy, including:

iliac/femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or accessories;
nonaneurysmal aortic diameter in the range of 18 mm to 42mm (fusiform and saccular aneurysms/penetrating ulcers), 18 mm to 44 mm (blunt traumatic aortic injuries), or 20 mm to 44 mm (dissections); and
nonaneurysmal aortic proximal and distal neck lengths ≥ 20mm (fusiform and saccular aneurysms/penetrating ulcers), landing zone ≥20 mm proximal to the primary entry tear (blunt traumatic aortic injuries, dissections). The proximal extent of the landing zone must not be dissected.

Contraindications

The Valiant Thoracic Stent Graft with the Captivia Delivery System is contraindicated in:

Patients who have a condition that threatens to infect the graft.
Patients with known sensitivities or allergies to the device materials.

Warnings and Precautions

The long-term safety and effectiveness of the Valiant Thoracic Stent Graft with the Captivia Delivery System has not been established. All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess the integrity and performance of the implanted endovascular stent graft. Patients with specific clinical findings (for example, enlarging aneurysm (>5mm), endoleaks, migration, inadequate seal zone, or continued flow into the false lumen in the case of a dissection) should receive enhanced follow-up. Specific follow-up guidelines are described in the Instructions for Use. The Valiant Thoracic Stent Graft with the Captivia Delivery System is not recommended in patients who cannot undergo, or who will not be compliant with, the necessary preoperative and postoperative imaging and implantation procedures as described in the Instructions for Use. Strict adherence to the Valiant Thoracic Stent Graft sizing guidelines as described in the Instructions for Use is expected when selecting the device size. Sizing outside of this range can potentially result in endoleak, fracture, migration, infolding, or graft wear. As cautioned in the Instructions for Use, a balloon should never be used when treating a dissection. The safety and effectiveness of the Valiant Thoracic Stent Graft with the Captivia Delivery System has not been evaluated in some patient populations. Please refer to the product Instructions for Use for details.

MRI Safety and Compatibility

Non-clinical testing has demonstrated that the Valiant Thoracic Stent Graft is MR Conditional. It can be scanned safely in both 1.5T and 3.0T MR systems under specific conditions as described in the product Instructions for Use. For additional information regarding MRI please refer to the product Instructions for Use.

Adverse Events

Potential adverse events include, but are not limited to access failure, access site complications (e.g. spasm, trauma, bleeding, rupture, dissection), adynamic ileus, allergic reaction (to contrast, antiplatelet therapy, stent graft material), amputation, anaesthetic complications, aortic expansion (e.g. aneurysm, false lumen), aneurysm rupture, angina, arrhythmia, arterial stenosis, atelectasis, blindness, bowel ischemia/infarction, bowel necrosis, bowel obstruction, branch vessel occlusion, buttock claudication, cardiac tamponade, catheter breakage, cerebrovascular accident (CVA) / stroke, change in mental status, coagulopathy, congestive heart failure, contrast toxicity, conversion to surgical repair, death, deployment difficulties / failures, dissection / perforation / rupture of the aortic vessel and/or surrounding vasculature, embolism, endoleak(s), excessive or inappropriate radiation exposure, extrusion / erosion, failure to deliver stent graft, femoral neuropathy, fistula (including aortobronchial, aortoenteric, aortoesophageal, arteriovenous, and lymph), gastrointestinal bleeding /complications, genitourinary complications, hematoma, hemorrhage / bleeding, hypotension / hypertension, infection or fever, insertion or removal difficulties, intercostal pain, intramural hematoma, leg /foot edema, lymphocele, myocardial infarction, neuropathy, occlusion – venous or arterial, pain / reaction at catheter insertion site, paralysis, paraparesis, paraplegia, paresthesia, perfusion of the false lumen, peripheral ischemia, peripheral nerve injury, pneumonia, post-implant syndrome, procedural / post-procedural bleeding, prosthesis dilatation / infection / rupture / thrombosis, pseudoaneurysm, pulmonary edema, pulmonary embolism, reaction to anaesthesia, renal failure, renal insufficiency, reoperation, respiratory depression / failure, sepsis, seroma, shock, spinal neurological deficit, stent graft material failure (including breakage of metal portion of device) / migration / misplacement / occlusion / twisting / kinking, transient ischemic attack (TIA), thrombosis, tissue necrosis, vascular ischemia, vascular trauma, wound dehiscence, wound healing complications, wound infection.

Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events.

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

BRIEF STATEMENT: VALIANT NAVION™ THORACIC STENT GRAFT SYSTEM

Indications

The Valiant Navion™ thoracic stent graft system is indicated for the endovascular repair of all lesions of the descending thoracic aorta (DTA) in patients having the appropriate anatomy including:

iliac or femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or accessories;
nonaneurysmal aortic diameter in the range of:
- 16 mm to 42 mm for fusiform and saccular aneurysms/penetrating ulcers
- 16 mm to 44 mm for blunt traumatic aortic injuries
- 19 mm to 45 mm for dissections;
proximal landing zone (nonaneurysmal aortic proximal neck length for fusiform and saccular aneurysms/penetrating ulcers or nondissected length of aorta proximal to the primary entry tear for blunt traumatic aortic injuries and dissections) of:
- ≥ 20 mm for FreeFlo configuration
- ≥ 25 mm for CoveredSeal configuration; and
nonaneurysmal aortic distal neck length ≥ 20 mm for FreeFlo and CoveredSeal configurations for fusiform and saccular aneurysms/penetrating ulcers.

Contraindications

The Valiant Navion thoracic stent graft system is contraindicated in the following patient populations:

Patients who have a condition that threatens to infect the graft
Patients who are sensitive to or have allergies to the device materials

Warnings and Precautions

The long-term safety and effectiveness of the Valiant Navion thoracic stent graft system has not been established. All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess the integrity and performance of the implanted endovascular stent graft. Specific follow-up guidelines are described in the Instructions for Use. Of note, patients with specific clinical findings should receive enhanced follow-up.

The Valiant Navion thoracic stent graft system is not recommended in patients who cannot undergo, or who will not be compliant with, the necessary preoperative and postoperative imaging and implantation procedures described in the Instructions for Use.

The safety and effectiveness of Valiant Navion thoracic stent graft system has not been evaluated in certain patient situations and/or populations. Please refer to product Instructions for Use for details.

Strictly adhere to the Valiant Navion thoracic stent graft system sizing configurations and guidelines as described in the Instructions for Use when selecting the device size. The appropriate device oversizing is incorporated into the sizing guidelines. Sizing outside of this range can potentially result in endoleak, fracture, migration, infolding, or graft wear.

Never use a balloon when treating a dissection.

Please refer to the product Instructions for Use for details.

MRI Safety and Compatibility

MRI may be used on the Valiant Navion thoracic stent graft only under specific conditions. 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 MRI please refer to the product Instructions for Use.

Adverse Events

Adverse events or complications associated with the use of the Valiant Navion thoracic stent graft system that may occur or require intervention include, but are not limited to: Access failure; Access site complications (for example: spasm, trauma, bleeding, rupture, dissection); Adynamic Ileus; Allergic reaction (to contrast, antiplatelet therapy, stent graft material); Amputation; Anaphylaxis; Anesthetic complications; Aneurysm rupture; Angina; Aortic expansion (for example: aneurysm, false lumen); Aortic valve damage; Aortic vessel rupture; Arrhythmia; Arterial stenosis; Atelectasis; Balloon rupture; Blindness; Bowel ischemia; Bowel necrosis; Bowel obstruction; Branch vessel occlusion; Breakage of the metal portion of the device; Buttock claudication; Cardiac tamponade; Catheter breakage; Cerebrovascular accident (CVA)/Stroke; Change in mental status; Coagulopathy; Congestive heart failure; Contrast toxicity; Conversion to surgical repair; Damage to the vessel; Death; Deployment difficulties/failures; Dissection, perforation, or rupture of the aortic vessel & surrounding vasculature; Embolism; Endoleaks; Excessive or inappropriate radiation exposure; Extrusion/erosion; Failure to deliver the stent graft; Femoral neuropathy; Fistula (including aortobronchia, aortoenteric, aortoesophogeal, arteriovenous, and lymph); Gastrointestinal bleeding/complications; Genitourinary complications; Hematoma; Hemorrhage/bleeding; Hypotension/hypertension; Infection or fever; Insertion or removal difficulty; Intercostal pain; Intramural hematoma; Leg edema/foot edema; Loss of patency; Lymphocele; Myocardial infarction; Neck enlargement; Nerve injury; Neuropathy; Occlusion - Venous or Arterial; Pain/reaction at catheter insertion site; Paralysis; Paraparesis; Paraplegia; Paresthesia; Perfusion of the false lumen; Peripheral ischemia; Peripheral nerve injury; Pneumonia; Postimplant syndrome; Post-procedural bleeding; Procedural bleeding; Prosthesis dilatation; Prosthesis infection; Prosthesis rupture; Prosthesis thrombosis; Pseudoaneurysm; Pulmonary edema; Pulmonary embolism; Reaction to anesthesia; Renal failure; Renal insufficiency; Reoperation; Respiratory depression or failure; Retrograde type A dissection; Sepsis; Seroma; Sexual dysfunction; Shock; Spinal neurological deficit; Stenosis; Stent graft migration; Stent graft misplacement; Stent graft occlusion; Stent graft rupture (for example: holes, tears); Stent graft twisting or kinking; Transient ischemic attack (TIA); Thrombosis; Tissue necrosis; Vascular ischemia; Vascular trauma; Wound dehiscence; Wound healing complications and Wound infection.

Please reference the product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events.

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

BRIEF STATEMENT: ENDURANT™ II/ENDURANT™ IIs BIFURCATED STENT GRAFT SYSTEM

Indications

The Endurant™ II/Endurant™ IIs bifurcated stent grafts are indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. They may be utilized in conjunction with the Heli-FX™ EndoAnchor™ system when augmented radial fixation and/or sealing is required; in particular, in the treatment of abdominal aortic aneurysms with short (≥ 4 mm and < 10 mm) infrarenal necks (see Neck length definition below). The Endurant II stent graft system aorto-uni-iliac (AUI) stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomy does not allow the use of a bifurcated stent graft. The Endurant II/IIs stent graft system is indicated for use in patients with the following characteristics:

Adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories

Proximal neck length of
- ≥ 10 mm; or
- ≥ 4 mm and < 10 mm when used in conjunction with the Heli-FX EndoAnchor system (bifurcated stent graft only)

Note: Neck length is defined as the length over which the aortic diameter remains within 10% of the infrarenal diameter.

Infrarenal neck angulation of ≤ 60°
Aortic neck diameters with a range of 19 to 32 mm
Distal fixation length(s) of ≥ 15 mm
Iliac diameters with a range of 8 to 25 mm
Morphology suitable for aneurysm repair

Contraindications

The Endurant II/Endurant IIs stent graft system is contraindicated in:

patients who have a condition that threatens to infect the graft
patients with known sensitivities or allergies to the device materials

When used with the Heli-FX EndoAnchor system, the Endurant II/IIs stent graft system is also contraindicated in:

patients with known sensitivities to the EndoAnchor implant materials.

For contraindications regarding ancillary devices used with the Endurant II/Endurant IIs stent graft system, refer to the Instructions for Use provided with the device.

Warnings and Precautions

The long-term safety and effectiveness of the Endurant II/Endurant IIs stent graft system has not been established. All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess the health and the performance of the implanted endovascular stent graft. Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms, changes in the structure or position of the endovascular graft), or less than the recommended number of EndoAnchor implants when used in short proximal necks (≥ 4 mm and < 10 mm), should receive enhanced follow-up. Specific follow-up guidelines are described in the Instructions for Use.

Patients experiencing reduced blood flow through the graft limb, aneurysm expansion, and persistent endoleaks may be required to undergo secondary interventions or surgical procedures.

The Endurant II/Endurant IIs stent graft system is not recommended in patients unable to undergo or who will not be compliant with the necessary preoperative and postoperative imaging and implantation procedures as described in the Instructions for Use.

Renal complications may occur: 1) From an excess use of contrast agents. 2) As a result of emboli or a misplaced stent graft. The radiopaque marker along the edge of the stent graft should be aligned immediately below the lower-most renal arterial origin.

Studies indicate that the danger of micro-embolization increases with increased procedure duration.

The safety and effectiveness of the Endurant II/Endurant IIs stent graft system has not been evaluated in some patient populations. Please refer to the product Instructions for Use for details.

MRI Safety and Compatibility

Non-clinical testing has demonstrated that the Endurant II/Endurant IIs stent graft is 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 MRI safety information, please refer to the product Instructions for Use.

Adverse Events

Potential adverse events include (arranged in alphabetical order): amputation; anesthetic complications and subsequent attendant problems (e.g., aspiration), aneurysm enlargement; aneurysm rupture and death; aortic damage, including perforation, dissection, bleeding, rupture and death; arterial or venous thrombosis and/or pseudoaneurysm; arteriovenous fistula; bleeding, hematoma or coagulopathy; bowel complications (e.g., ileus, transient ischemia, infarction, necrosis); cardiac complications and subsequent attendant problems (e.g., arrhythmia, myocardial infarction, congestive heart failure, hypotension, hypertension); claudication (e.g., buttock, lower limb); death; edema; EndoAnchor system (for infrarenal EVAR procedures using the Heli-FX EndoAnchor system): partial deployment, inaccurate deployment, fracture, dislodgement, embolization, stent graft damage, modelling balloon damage); embolization (micro and macro) with transient or permanent ischemia or infarction; endoleak; fever and localized inflammation; genitourinary complications and subsequent attendant problems (e.g., ischemia, erosion, femoral-femoral artery thrombosis, fistula, incontinence, hematuria, infection); hepatic failure; impotence; infection of the aneurysm, device access site, including abscess formation, transient fever and pain; lymphatic complications and subsequent attendant problems (e.g., lymph fistula); neurologic local or systemic complications and subsequent attendant problems (e.g., confusion, stroke, transient ischemic attack, paraplegia, paraparesis, paralysis); occlusion of device or native vessel; pulmonary complications and subsequent attendant problems; renal complications and subsequent attendant problems (e.g., artery occlusion, contrast toxicity, insufficiency, failure); stent graft: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft twisting and/or kinking; insertion and removal difficulties; graft material wear; dilatation; erosion; puncture and perigraft flow; surgical conversion to open repair; vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula, dissection; vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection, bleeding, rupture, death); vessel damage; wound complications and subsequent attendant problems (e.g., dehiscence, infection, hematoma, seroma, cellulitis)

Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events.

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

BRIEF STATEMENT: HELI-FX™ & HELI-FX™ THORACIC ENDOANCHOR™ SYSTEMS

Indications for Use

The Heli-FX^™ EndoAnchor^™ system is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX^™ EndoAnchor^™ system is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion. The EndoAnchor^™ implant may be implanted at the time of the initial endograft placement, or during a secondary (i.e. repair) procedure.

Contraindications

Treatment with the Heli-FX^™ EndoAnchor^™ system is contraindicated for use in the following circumstances:

In patients with known allergies to the EndoAnchor^™ implant material (MP35N-LT)
In conjunction with the Endologix Powerlink^™^* endograft

Warnings

The long-term performance of the EndoAnchor^™ implant has not been established. All patients should be advised endovascular aneurysm treatment requires long-term, regular follow-up visits to assess the patient’s health status and endograft performance. The EndoAnchor^™ implant does not reduce this requirement.

The EndoAnchor^™implant and the Heli-FX™ EndoAnchor^™ system have been evaluated via in vitro testing and determined to be compatible with the Cook Zenith^™^*, Cook Zenith^™* TX2^™^*, Gore Excluder^™*, Gore TAG^™*, Medtronic AneuRx^™, Medtronic Endurant^™, Medtronic Talent^™AAA, Medtronic Talent™ TAA, Medtronic Valiant Xcelerant™, Medtronic Valiant™ Captivia™, and Medtronic Valiant Navion™ endografts. Use with endografts other than those listed above has not been evaluated.

The performance of the EndoAnchor^™ implant has not been evaluated for securing multiple endograft components together. Not securing EndoAnchor^™ implants into aortic tissue could result in graft fabric damage, component separation, and resultant Type III endoleaks.

The performance of the EndoAnchor^™ implant has not been evaluated in vessels other than the aorta. Use of the EndoAnchor^™ implant to secure endografts to other vessels may result in adverse patient consequences such as vascular perforation, bleeding, or damage to adjacent structures.

The performance of the EndoAnchor^™ implant has not been evaluated for securing multiple anatomical structures together. Such use could result in adverse patient consequences such as vascular perforation, bleeding, or embolic events.

MRI Safety and Compatibility

The EndoAnchor^™ implants have been determined to be MR Conditional at 3T or less when the scanner is in Normal Operating Mode with whole-body-averaged SAR of 2 W/kg, or in First Level Controlled Mode with a maximum whole-body-averaged SAR of 4 W/kg.

Please refer to documentation provided by the endograft system manufacturer for MR safety status of the endograft system with which the EndoAnchor^™ implants are being used.

Potential Adverse Events

Possible adverse events that are associated with the Heli-FX™ EndoAnchor^™system, include, but are not limited to:

Aneurysm rupture
Death
EndoAnchor™ implant embolization
Endoleaks (Type III)
Enteric fistula
Failure to correct/prevent Type I endoleak
Failure to prevent endograft migration
Infection
Renal complications (renal artery occlusion/dissection or contrast-induced acute kidney injury)
Stroke
Surgical conversion to open repair
Vascular access complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula
Vessel damage, including dissection, perforation, and spasm

Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events. Additional potential adverse events may be associated with endovascular aneurysm repair in general. Refer to the Instructions for Use provided with the endograft for additional potential adverse events.

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a licensed healthcare practitioner. See package inserts for full product information.

CAUTION: EndoAnchor^™ implant locations should be based upon a detailed examination of the preoperative CT imaging in cases involving irregular or eccentric plaque in the intended sealing zones. EndoAnchor^™ implants should be implanted only into areas of aortic tissue free of calcified plaque or thrombus, or where such pathology is diffuse and less than 2mm in thickness. Attempting to place EndoAnchor^™ implants into more severe plaque or thrombus may be associated with implantation difficulty and suboptimal endograft fixation and/or sealing.

TM* Third party brands are trademarks of its respective owner. All other brands are trademarks of a Medtronic company.

BRIEF STATEMENT: TOURGUIDE™ STEERABLE SHEATH

CAUTION: Federal Law restricts this device to sale by or on the order of a physician (U.S.A.). Please refer to the Instructions for Use for a complete listing of the indications, contraindications, precautions and warnings, where applicable.

Important Information

Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, suggested procedure, warnings and precautions. Failure to properly follow the instructions for use, warnings, and precautions may lead to serious consequences or injury to the patient.

Indications for Use

The steerable sheath, model TourGuide™ is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

Contraindications:

Known active or systemic local infection
Known inability to obtain vascular access
Patients with atrial thrombosis or myxoma, or interatrial baffle or patch
Use of a steerable sheath is contraindicated in patients with obstructive or inadequate vasculature

Potential Adverse Events

Possible adverse events associated with the use of TourGuide™ Steerable Sheath include, but are not limited to:

Air Embolism
Allergic reaction to contrast media
Aortic puncture
Arrhythmias
Arteriovenous fistula formation
Atrial septal defect
Bleeding plexus injury
Catheter entrapment
Cardiac tamponade
Coronary artery spasm and/or damage
Dislodgement
Dissection
Endocarditis
Heart Block
Hematoma formation
Hemorrhage
Hemothorax
Infection
Intimal tear
Irregular heart beat
Local nerve damage
Mediastinal widening
Myocardial infarction
Pacemaker/defibrillator lead displacement
Perforation
Pericardial/pleural effusion
Pneumothorax
Pseudoaneurysm formation
Pulmonary edema
Stroke
Subclavian artery puncture
Thromboembolic events
Thrombophlebitis
Valve damage
Vascular occlusion
Vasovagal reaction
Vessel damage/Vessel trauma
Vessel spasm

PRECAUTIONS

Transvenous device compatibility: Use the steerable sheath only with compatible transvenous devices. Use the appropriate size sheath for the size of the transvenous device being utilized. Consequences of using the steerable sheath with incompatible devices may include the inability to deliver the transvenous device or damage to the transvenous device during delivery.

WARNING

If the patient has left bundle branch block, back up pacing should be readily available during insertion of the steerable sheath assembly. Use of the steerable sheath assembly may cause heart block.

BRIEF STATEMENT: SENTRANT™ INTRODUCER SHEATH

Important Information

Prior to use, refer to the Instructions for Use for indications, contraindications, suggested procedure, warnings and precautions.

Indications for Use

The Medtronic Sentrant™ Introducer Sheaths with Hydrophilic Coating are intended to provide a conduit for the insertion of diagnostic or endovascular devices into the vasculature and to minimize blood loss associated with such insertions.

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

BRIEF STATEMENT: RELIANT™ STENT GRAFT BALLOON CATHETER

Important Information

Prior to use, refer to the Instructions for Use for indications, contraindications, suggested procedure, warnings and precautions.

Indications for Use

The Reliant™ Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels or to expand vascular prostheses. The device is intended to assist in the expansion of self-expanding stent grafts.

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

BRIEF STATEMENT: TALENT™ OCCLUDER WITH OCCLUDER DELIVERY SYSTEM

Indications

The Talent™ Occluder with Occluder Delivery system is intended for endoluminal occlusion of the common iliac artery in order to prevent retrograde blood into the aneurysm sac when used in conjunction with a fem-fem bypass (for example, the Talent Occluder can be used in combination with the Talent Converter Stent Graft).

The anatomical considerations are as follows:

• Iliac/femoral access vessel morphology that is compatible with vascular access techniques and a delivery system profile of 17.5 French

• Common iliac vessel diameters between 6 mm and 20 mm

Contraindications

The Talent Occluder is contraindicated in:

• Patients who have a condition that threatens to infect the graft

• Patients with sensitivities or allergies to the device materials

Warnings and Precautions

• The long-term performance of the Talent Occluder has not yet been established. All patients receiving the Talent Occluder should receive enhanced follow-up. Specific follow-up guidelines are described in the Instructions for Use.

• Renal complications may occur: 1) From an excess use of contrast agents 2) As a result of emboli.

• Studies indicate that the danger of micro-embolization increases with increased duration of the procedure.

• The safety and effectiveness of the Talent Occluder System has not been evaluated in some patient populations. Please refer to the product Instructions for Use for details.

MRI Safety and Compatibility:

Non-clinical testing has demonstrated that the Talent Occluder is 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 MRI please refer to the product Instructions for Use.

Potential Adverse Events

Potential adverse events include (not arranged in any particular order): Aneurysm enlargement; aneurysm rupture and death; aortic damage (including perforation, dissection, bleeding, rupture and death); arterial or venous thrombosis and/or pseudoaneurysm; bleeding, hematoma or coagulopathy; cardiac complications and subsequent attendant problems; claudication; dislodgement of pre-existing graft (for example, a Talent Converter); death; embolization (micro and macro) with transient or permanent ischemia or infarction; endoleak; fever and localized inflammation; pulmonary/respiratory complications; renal complications; surgical conversion to open repair; vascular access site complications ;vascular spasm or vascular trauma; vessel damage; wound complications and subsequent attendant problems; stent graft complications: improper component placement, incomplete component deployment, component migration, suture break, occlusion, infection, stent fracture, graft twisting and/or kinking, insertion and removal difficulties, graft material wear, dilatation, erosion, puncture, and perigraft flow.

Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events.

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

Last updated:

11 Jun 2020