INDICATIONS, SAFETY, AND WARNINGS

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.

FTSOP113326-81 Rev. 1A