INDICATIONS, SAFETY, AND WARNINGS
Thoracic Stent Graft System
Thoracic Stent Graft System
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:
The Valiant Navion thoracic stent graft system is contraindicated in the following patient populations:
Please refer to the product Instructions for Use for details.
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 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