Valiant

Endurant II/Endurant IIs Stent Graft System

Brief Statement

Indications
The Endurant™ II/Endurant™ IIs bifurcated stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms. The Endurant II 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/Endurant IIs stent graft system is indicated for use in patients with the following characteristics:

• Adequate iliac/femoral access that is compatible with vascular access techniques, devices and/or accessories
• Proximal neck length of ≥10 mm
• 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

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 or changes in the structure or position of the endovascular graft) 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 studies 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 duration of the procedure.
• 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 information regarding MRI 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; 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: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. 

FTSOP113326-06 Rev. 1E

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Heli-FX & Heli-FX Thoracic EndoAnchor Systems

Reference Statement

Indications for Use
The Aptus Heli-FX™ EndoAnchor™ System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Aptus 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 may be implanted at the time of the initial endograft placement, or during a secondary (i.e. repair) procedure.

Contraindications
Treatment with the Aptus 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 has not been established. All patients should be advised endovascular aneurysm treatment requires long-term, regular follow-up to assess the patient's health status and endograft performance, and the EndoAnchor does not reduce this requirement.
• The EndoAnchor implant and the Aptus 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™, and Medtronic Valiant™ endografts. Use with endografts other than those listed above has not been evaluated.
• The performance of the EndoAnchor has not been evaluated for securing multiple endograft components to one another. Without EndoAnchor securement into aortic tissue, this could result in graft fabric damage, component separation, and resultant Type III endoleaks.
• The performance of the EndoAnchor has not been evaluated in vessels other than the aorta. Use of the EndoAnchor to secure endografts to other vessels may result in adverse patient consequences such as vascular perforation, bleeding, or damage to adjacent structures.
• The Aptus EndoAnchor 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 EndoAnchors 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 EndoAnchors are being used.

Potential Adverse Events
Possible adverse events associated with the use of Aptus Heli-FX EndoAnchor include, but are not limited to:

• Aneurysm rupture
• Death
• EndoAnchor 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 AKI)
• 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.

Caution: Swedish 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 zone(s). EndoAnchors 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 EndoAnchors into more severe plaque or thrombus may be associated with implantation difficulty and suboptimal endograft fixation and/or sealing.

FTSOP113326-33 Rev. 1B

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Reliant Stent Graft Balloon Catheter

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 Reliant™ Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels or to expand vascular prostheses.

Caution: Swedish law restricts these devices to sale by or on the order of a licensed healthcare practitioner. See package inserts for full product information.

FTSOP113326-11 Rev. 1B

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Sentrant Introducer Sheath with Hydrophilic Coating

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

FTSOP113326-05 Rev. 1C

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TourGuide Steerable Sheath

Reference Statement

See the Instructions for Use which accompany each product for detailed information regarding the indications, contraindications, warnings, precautions, and potential complications/adverse events.

Caution: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. 

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.

If the indications for use of the device are discussed, the following statement must appear:

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

Precaution
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.

FTSOP113326-34 Rev. 1A

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Valiant Thoracic Stent Graft System

Expanded Indication Brief Statement

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

• iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories;
• nonaneurysmal aortic diameter in the range of 18 mm to 42 mm (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 ≥20 mm (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, 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 Effects
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: Swedish law restricts this product for sale by or on the order of a physician

FTSOP113326-22 Rev. 1B

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