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 Valve 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.

Potential Adverse Events

Certain complications may occur with heart valve procedures. The adverse events potentially associated with the use of mechanical heart valves include: cardiac arrhythmias, death, leaflet entrapment (impingement), endocarditis, hemolysis, anticoagulant-related hemorrhage, transvalvular or perivalvular leak, prosthesis thrombosis, structural deterioration, valve thromboembolism.

Adverse events potentially associated with the use of vascular grafts include: 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, or 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 valve for a complete listing of warnings and precautions.