BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 1677664 · Received May 8, 2010

    Report

    Report Number
    2015691-2010-13307
    Event Type
    Death
    Date Received
    May 8, 2010
    Date of Event
    February 22, 2010
    Report Date
    April 7, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED; DEVICE WAS NOT EXPLANTED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THIS PATIENT ALSO HAS ANOTHER RELATED EVENT; (B) (6). THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER (VIA FAX), A COPY OF AN OPERATIVE REPORT FOR A PREVIOUS SURGERY WAS RECEIVED, HOWEVER, NO FURTHER INFORMATION REGARDING THIS EVENT WAS PROVIDED. UNFORTUNATELY, THE CAUSE OF DEATH REMAINS UNKNOWN. THE DEVICE IS NOT AVAILABLE FOR EVALUATION, AS THE DEVICE WAS NOT EXPLANTED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF 0.2 MONTHS, DUE TO UNKNOWN REASONS. THROUGH FOLLOW-UP, ONLY A COPY OF AN OPERATIVE REPORT FOR A PREVIOUS SURGERY WAS RECEIVED. NO INFORMATION REGARDING THE REPORTED EVENT WAS LEARNED. THE CAUSE OF DEATH REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX R-09K2393

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death