Medtronic received information via literature review regarding pathological analysis of the freestyle aortic root bioprosthesis treated with amino oleic acid.All data were collected from multiple centers.The study population included 1,100 patients.The study population was predominantly male.Serial numbers were not provided.Among all patients, valve related deaths included; endocarditis, thrombus, embolic myocardial infarction (mi), delayed tamponade, sub annular occlusion and paravalvular leak (pvl).No additional adverse patient effects or product performance issues were reported.
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