BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® SUPRAANNULAR BIOPROSTHESIS

    MDR report key: 7400906 · Received April 5, 2018

    Report

    Report Number
    2015691-2018-01257
    Event Type
    Injury
    Date Received
    April 5, 2018
    Date of Event
    March 14, 2018
    Report Date
    March 14, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL #: THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL # 6625-LP; BRAND NAME: CARPENTIER-EDWARDS® DURAFLEX® LOW PRESSURE MITRAL BIOPROSTHESIS; PMA #P870077. LEAFLET NOT COAPTING TYPICALLY WOULD RESULT IN REGURGITATION. REGURGITATION OF BIOPROSTHETIC VALVES MAY BE, DEPENDING ON THE SEVERITY, INDICATION FOR RE-OPERATION AND REPLACEMENT OF THE VALVE, WHICH INCREASES THE RISK FOR POST-OPERATIVE MORTALITY. REGURGITATION, WHICH DEVELOPS PROGRESSIVELY OVER TIME, CAN BE DUE TO A NUMBER OF ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION. STRUCTURAL VALVE DETERIORATION (SVD) IS THE MOST COMMON REASON FOR BIOPROSTHESES 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. REGURGITATION MAY ALSO DEVELOP PROGRESSIVELY IF HOST FIBROTIC TISSUE, OR PANNUS, GROWS ONTO THE BIOPROSTHETIC VALVE. PANNUS, A CAUSE OF NONSTRUCTURAL DYSFUNCTION, MAY INTERFERE WITH FUNCTIONALITY OF THE DEVICE BY RESTRICTING THE LEAFLET MOTION LEADING TO ABNORMAL COAPTATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINED IMPLANTED. IN THIS CASE, 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. HOWEVER IT IS LIKELY THAT PATIENT RELATED FACTORS CONTRIBUTED TO THE EVENT. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING AND STERILIZATION SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. 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.

    Description of Event or Problem · 1

    EDWARDS RECEIVED NOTIFICATION THAT 31MM PORCINE MITRAL VALVE UNDERWENT A VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS AND TEN (10) MONTHS DUE TO A LEAFLET FLAP OF THE ANTERIOR LEAFLET LEADING TO A CENTRAL LEAK AS THE LEAFLET DID NOT CLOSE PROPERLY. A 29MM TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED VIA THE TRANSSEPTAL APPROACH. THE PATIENT WAS NOTED AS TO BE DOING WELL. NO ECHO IMAGES WERE AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242345 CARPENTIER-EDWARDS® SUPRAANNULAR BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 665031MM

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| R