BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 10271838 · Received July 14, 2020

    Report

    Report Number
    2015691-2020-12517
    Event Type
    Injury
    Date Received
    July 14, 2020
    Date of Event
    June 10, 2020
    Report Date
    June 19, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    BIOPROSTHETIC TISSUE VALVES CAN DETERIORATE WITH TIME AND EVENTUALLY FAIL CONTRIBUTING TO REGURGITATION AND/OR STENOSIS. STRUCTURAL VALVE DETERIORATION (SVD) IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANTS AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR REGURGITATION AND/OR STENOSIS. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. HOWEVER, THIS EVENT WAS MOST LIKELY IMPACTED BY THE PROGRESSION OF THE PATIENT¿S UNDERLYING VALVULAR DISEASE PATHOLOGY WITH OR WITHOUT SVD AND/OR NSVD. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. THERE WERE NO ISSUES IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH A 27MM 7300TFX (CP-2020-10235-1) PERICARDIAL MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, 10 MONTHS DUE TO SEVERE SYMPTOMATIC MITRAL STENOSIS REGURGITATION. THE TMVR PROCEDURE WAS PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE. A SMALL ANTERIORLY DIRECTED PARAVALVULAR LEAK WAS NOTED. THE PATIENT WAS TAKEN TO THE ICU IN STABLE AND AWAKE CONDITION. THERE WERE NO COMPLICATIONS AND THE PROCEDURE WAS TOLERATED WELL. THE PATIENT WAS DISCHARGED HOME ON POD #2 IN STABLE CONDITION. PER RECEIVED MEDICAL RECORDS IT WAS LEARNED THAT THE PATIENT'S 21MM 3300TFX (CP-2020-10235-2) PERICARDIAL AORTIC VALVE HAD EXHIBITED SEVERE DYSFUNCTION AND HAD UNDERGONE VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF APPROXIMATELY SEVEN (7) YEARS, EIGHT (8) MONTHS. THE TAVR PROCEDURE WAS NOTED TO HAVE BEEN UNEVENTFUL. MODEL NUMBER AND SIZE OF THE TRANSCATHETER VALVE IMPLANTED IN THE AORTIC POSITION IS UNKNOWN. THE PATIENT WAS NOTED TO HAVE BEEN DOING WELL IN THE TWO (2) MONTHS PRIOR TO THE TMVR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736033 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX21MM

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R