BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL MITRAL BIOPROSTHESIS

    MDR report key: 1707926 · Received June 2, 2010

    Report

    Report Number
    2015691-2010-13479
    Event Type
    Death
    Date Received
    June 2, 2010
    Date of Event
    April 18, 2010
    Report Date
    May 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE PATIENT ALSO HAD ANOTHER DEVICE IMPLANTED; (B) (4). THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER (VIA FAX), ADDITIONAL INFORMATION AND A COPY OF THE OPERATIVE REPORT WAS RECEIVED ON 05/12/2010. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    ON 06/03/2010, THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER VIA TELPHONE, IT WAS LEARNED THAT THE EVENT WAS NOT DEVICE RELATED. THE SURGEON HAS DISASSOCIATED THE DEVICE FROM THE EVENT; THEREFORE, IT HAS BEEN DETERMINED THAT THIS EVENT IS NO LONGER REPORTABLE TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 0.4 MONTHS. ON 05/12/2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), IT WAS LEARNED THAT THE CAUSE OF DEATH WAS CARDIAC FAILURE.

    Description of Event or Problem · 1

    A PATIENT FILLED WITH 2000 ML ON THE HOMCHOICE DEVICE. THE PATIENT TRIED THE INITIAL DRAIN AND THE CYCLER WENT TO FILL 1 WITH NO DRAIN. THE PATIENT PERFORMED A MANUAL DRAIN OF 4131ML. THIS DRAIN VOLUME MEETS INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL MITRAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX R-09E1241

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death