BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 1666311 · Received April 25, 2010

    Report

    Report Number
    2015691-2010-13211
    Event Type
    Death
    Date Received
    April 25, 2010
    Date of Event
    December 16, 2009
    Report Date
    March 26, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER (VIA EMAIL), THE OPERATIVE REPORT WAS RECEIVED. UNFORTUNATELY, THE CAUSE OF DEATH WAS NOT PROVIDED. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN 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 APPROXIMATELY 0.6 MONTHS. ON 04/20/2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), A RESPONSE WAS RECEIVED. UNFORTUNATELY, THE CAUSE OF DEATH WAS NOT PROVIDED.

    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 08E117

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death