BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 1654244 · Received April 8, 2010

    Report

    Report Number
    2015691-2010-13077
    Event Type
    Death
    Date Received
    April 8, 2010
    Date of Event
    December 22, 2009
    Report Date
    March 12, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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), A RESPONSE WAS RECEIVED; HOWEVER, NO ADDITIONAL INFORMATION WAS NOT PROVIDED. THE CAUSE OF DEATH REMAINS UNKNOWN. 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 IMPLANT DURATION OF APPROXIMATELY 4 MONTHS. ON (B) (6) 2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), A RESPONSE WAS RECEIVED; HOWEVER, NO ADDITIONAL INFORMATION WAS NOT PROVIDED. THE CAUSE OF DEATH REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A BLANK DISPLAY AND WOULD NOT RESPOND TO ANY BUTTONS, A LOCK-UP FAILURE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-09E1207

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death