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Medtronic Open Pivot Aortic Valved Graft (AVG)

Indications, Safety, and Warnings

Indications

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.

Contraindications

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.

Warning

The graft should not be implanted in patients with a known sensitivity to products of bovine origin.

Potential Adverse Events

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: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. Refer to the Instructions for Use packaged with each aortic valved graft for a complete listing of warnings and precautions.