The Medtronic Open Pivot™ heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves.
The Medtronic Open Pivot™ heart valve is contraindicated in patients unable to tolerate anticoagulation therapy.
Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device.: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction.
Adverse events potentially associated with the use of prosthetic heart valves include leaflet entrapment (impingement), transvalvular regurgitation, structural dysfunction, pannus, perivalvular leak, transvalvular leak, thrombosis, stroke, thromboembolism. 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 valve for a complete listing of warnings and precautions.
The Medtronic Open Pivot™ aortic valved graft (AVG) 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 AVG is contraindicated in patients unable to tolerate anticoagulation therapy. The HemashieldTM* 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.
Adverse events potentially associated with the use of prosthetic aortic heart 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.
UC202409148EN
Find more information, including other available configurations, for Medtronic Open Pivot™ mechanical heart valve.
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