Medtronic received information via literature regarding the long-term results of mitral valve repair for correcting regurgitation following leaflet prolapse.All data were collected from multiple centers between 1981 and 2010.The study population included 1234 patients (predominantly male, median age 59 years), 339 of which were implanted with medtronic simplici-t annuloplasty bands (no serial numbers provided).Among all patients, 324 deaths occurred throughout the follow-up period.It was reported that 7 deaths occurred within 90 days of implant, and 317 deaths occurred beyond 90 days post implant.Of the late-stage deaths, 115 were classified as cardiac, 193 non-cardiac, and 9 unknown cause.Furthermore, 2 deaths occurred during reoperation, 2 deaths occurred from endocarditis, 14 deaths occurred following a stroke, 11 deaths occurred from major bleeding, and 1 death occurred from heart failure.Multiple manufacturers were noted in the literature, and there was no association between medtronic product and any of the deaths.Based on the available information medtronic product was not directly associated with the deaths.Among all patients, adverse events included: infective endocarditis, thromboembolism, stroke, transient ischemic attack (tia), major bleeding, hemolysis, systolic anterior motion, stenosis, pannus formation, heart failure, moderate-severe mitral regurgitation, mod erate-severe tricuspid regurgitation, pacemaker implantation, atrial fibrillation.A total of 48 patients required reoperation.Based on the available information medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.
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