Citation: finch, jonathan.Failing stentless aortic valves: redo aortic root replacement or valve in a valve? european journal of cardio-thoracic surgery.(2012).43: 495¿504 doi 10.1093/ejcts/ezs335 earliest date of e-publish/publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it cannot be determined whether this event has been previously reported.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information via literature review regarding redo aortic root replacement versus valve-in-valve treatment for failed stentless aortic valves.All data were collected from a single center between 2000 and 2010.The study population included a total of 101 patients.Sixty-five patients (predominantly male; average age 61.5 ± 14.2 years) underwent a valve-in-valve replacement (group a).Forty-five patients (predominantly male; average age 61.9 ± 12.1 years), underwent a redo root replacement (group b).Group b contained one patient who had been implanted with a medtronic freestyle aortic root (serial numbers not provided).During the redo procedure medtronic mosaic, mosaic ultra and freestyle valve were implanted.Among all patients implanted with a mosaic or mosaic ultra, adverse events included: electrocardiogram (ecg) changes treated with a permanent pacemaker, cerebral vascular accident (cva), bleeding treated with re-sternotomy, structural deterioration and aortic regurgitation.Based on the available information, these events may have been attributed to a medtronic product, however a direct correlation could not be made between the observed adverse events and medtronic product.No additional adverse patient effects or product performance issues were reported.
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