BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESES

    MDR report key: 3822131 · Received May 20, 2014

    Report

    Report Number
    2015691-2014-01195
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 21, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. THE DEVICE IS NOT AVAILABLE FOR RETURN AND EVALUATION BECAUSE IT HAS BEEN DISCARDED BY THE HOSPITAL. ALTHOUGH BIOPROSTHETIC VALVES HAVE BEEN PROVEN TO HAVE EXCELLENT LONG TERM DURABILITY, FAILURE DOES OCCUR IN A SMALL NUMBER OF VALVES. REPLACEMENT OF A BIOPROSTHETIC VALVE OVER TIME IS MORE LIKELY DUE TO STRUCTURAL VALVE DETERIORATION (SVD) WHICH OCCURS AS A RESULT OF STENOSIS (FROM CALCIFICATION OR HOST TISSUE OVERGROWTH), DEHISCENCE, FIBROSIS OR NON-CALCIFIC DEGENERATION. IN THIS CASE, INFORMATION REGARDING THIS VALVE EXPLANT WAS RECEIVED THROUGH OUR IMPLANT PATIENT REGISTRY PROCESS AND SUBSEQUENT ATTEMPTS TO GET ADDITIONAL INFORMATION REGARDING THE CONDITION OF THE DEVICE OR THE EVENT SURROUNDING THE EXPLANT WERE UNSUCCESSFUL; THEREFORE, THE ROOT CAUSE FOR EXPLANT OF THIS DEVICE REMAINS INDETERMINABLE.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THROUGH ITS IMPLANT PATIENT REGISTRY THAT A 31MM MITRAL BIOPROSTHETIC VALVE, IMPLANTED ONE (1) MONTH AND TWENTY-SIX (26) DAYS, WAS EXPLANTED DUE TO UNKNOWN REASONS AND REPLACED WITH A 27MM MODEL 7300TFX MITRAL VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300532 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESES HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 7300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R