BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS SUPRAANNULAR BIOPROSTHESIS

    MDR report key: 10438010 · Received August 21, 2020

    Report

    Report Number
    2015691-2020-13250
    Event Type
    Injury
    Date Received
    August 21, 2020
    Date of Event
    July 28, 2020
    Report Date
    July 28, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS, MODEL# 6625-LP, PMA# P870077. TISSUE DEGENERATION RELATED STRUCTURAL DETERIORATION EITHER CALCIFIC OR NON-CALCIFIC ARE COMMON CHRONIC FAILURE MODES FOR THIS TYPE OF BIOPROSTHETIC HEART VALVES. THE OPERATIONAL MECHANICAL STRESS AND BIOLOGICAL FACTORS ARE GENERALLY BELIEVED TO BE THE MAJOR CONTRIBUTORS TO THE NON-CALCIFIC BIOPROSTHETIC TISSUE DEGENERATION. STRUCTURAL VALVE DETERIORATION (SVD) CAN, AND TYPICALLY DOES, LEAD TO CHRONIC CENTRAL LEAKS OVER A PERIOD OF TIME. SVD IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANT AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NONCALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINS IMPLANTED. THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS AND THE PROGRESSION OF THE UNDERLYING VALVULAR DISEASE PATHOLOGY CONTRIBUTED TO THE EVENT. 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.

    Description of Event or Problem · 1

    EDWARDS RECEIVED NOTIFICATION THAT A 33MM VALVE IMPLANTED IN AN UNKNOWN POSITION WAS DISABLED VIA A VALVE-IN-VALVE REPLACEMENT AFTER AN APPROXIMATE IMPLANT DURATION OF 17 YEARS AND 6 MONTHS DUE TO DEGENERATION LEADING TO STENOSIS AND REGURGITATION. A 29MM TRANSCATHETER VALVE WAS IMPLANTED WITH GOOD RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900116 CARPENTIER-EDWARDS SUPRAANNULAR BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 6650

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R