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Patient 1
STENOSIS AND/OR REGURGITATION, WHICH DEVELOPS PROGRESSIVELY OVER TIME, CAN BE DUE TO A NUMBER OF ISSUES. ADDITIONALLY, THERE CAN BE A NUMBER OF POTENTIAL KNOWN AND UNKNOWN PATIENT RELATED CONTRIBUTING FACTORS. STRUCTURAL VALVE DETERIORATION (SVD), A COMMON REASON FOR BIOPROSTHESIS EXPLANT OR REOPERATION, ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFIC AND NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES, OCCURRING SINGULARLY OR CONCOMITANTLY, MAY CONTRIBUTE TO STENOSIS AND/OR REGURGITATION. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR STENOSIS AND/OR REGURGITATION. STENOSIS AND/OR REGURGITATION IS MOST COMMONLY RELATED TO PATIENT FACTORS, AND IS NOT USUALLY AN INDICATION OF A DEVICE MALFUNCTION. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINS IMPLANTED. MINIMAL INFORMATION REGARDING THIS PROCEDURE WAS RECEIVED AND ATTEMPTS TO GET ADDITIONAL INFORMATION REGARDING THE CONDITION OF THE DEVICE, PATIENT'S MEDICAL HISTORY, OR POSSIBLE COMORBIDITIES HAVE BEEN UNSUCCESSFUL. THE ROOT CAUSE OF THE EVENT REMAINS INDETERMINABLE. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE HISTORY RECORD (DHR) WAS NOT ABLE TO BE REVIEWED AS THE DEVICE SERIAL NUMBER WAS NOT PROVIDED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.