Medtronic received information via literature regarding long-term outcomes of the mosaic bioprosthesis.All data were collected from multiple centers between february 1994 and november 2000.The study population included 1,029 patients (predominantly male; mean age 69 years), 797 patients were implanted with medtronic mosaic valve in aortic position and 232 patients were implanted with medtronic mosaic valve in mitral position.The serial numbers were not provided.Among all patients 37 deaths were characterized as valve-related due to permanent neurological event, endocarditis, structural valve dysfunction (svd), sepsis, myocardial infarction (mi), congestive heart failure (chf), cardiac failure and hemorrhage.Based on the available information, none of these deaths were attributed to medtronic product.Among all patients adverse events included: structural valve dysfunction (svd) in form of calcification, tears and perforations, degeneration, fenestration, refraction, and prolapse of the non-coronary cusp, severe aortic regurgitation (ar),moderate mitral regurgitation, mitral stenosis, aortic stenosis, bleeding, valve thrombosis, thromboembolism and permanent neurological event.Based on the available information, a direct correlation was likely between the observed adverse events and medtronic product.No additional adverse patient effects or product performance problems were reported.
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Additional review revealed the study referenced within the literature to be sponsored by medtronic, and that the clinical observations from the study population have been previously reported at the patient level.If information is provided in the future, a supplemental report will be issued.
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