The Medtronic Open Pivot™ Aortic Valved Graft is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves, where a replacement valve and replacement or repair of the aorta is required.
The Medtronic Open Pivot Aortic Valved Graft is contraindicated in patients unable to tolerate anticoagulation therapy. The Hemashield® Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement.
The graft should not be implanted in patients with a known sensitivity to products of bovine origin.
Certain complications may occur with heart valve procedures. The adverse events potentially associated with the use of prosthetic aortic valves include, but are not limited to: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment (impingement), nonstructural dysfunction, pannus, perivalvular leak, transvalvular regurgitation, structural dysfunction, thrombosis, stroke, thromboembolism.
Adverse events potentially associated with the use of vascular grafts include, but are not limited to: aneurysm; clinical reaction to collagen (shown to be a weak immunogen) described as infrequent, mild, localized, and self limiting; embolism; hemorrhage; infection; occlusion (including thrombosis and anastomotic intimal hyperplasia); pseudoaneurysm; seroma.
It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death.
CAUTION: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions.