Medtronic received information from a literature article regarding the outcomes of patients on hemodialysis who underwent surgical aortic valve replacement.All data were retrospectively collected from a single center between july 2008 to december 2016.The study population included 76 patients and was predominantly male with a mean age of 70 years.Of those, 5 patients were implanted with medtronic mosaic surgical aortic valves and 5 patients were implanted with medtronic ats mechanical aortic valves.No serial numbers were provided.Among all patients, 32 deaths occurred during the follow-up period of approximately 6.7 years.The causes of the deaths included: heart failure, infection, cerebrovascular event, mesenteric ischemia, and unknown cause.Multiple manufacturers devices were implanted in the study population.None of the deaths were directly associated with medtronic product.Among all patients, adverse events included: post-operative stroke, sepsis, need for prolonged ventilation, patient-prosthesis mismatch, atrial fibrillation, bleeding complications, and gastrointestinal complications.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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