It was reported that a patient with a 23mm 11500a aortic valve is under evaluation for a valve-in-valve procedure after an implant duration of one (1) year, ten (10) months due to moderate to severe pvl.Tavr has not been scheduled.Per consult note, 2 separate jets noted on tee.More significant jet noted to left coronary cusp, second originating in non-coronary cusp.
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H10: additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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