BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

    MDR report key: 1063117 · Received June 18, 2008

    Report

    Report Number
    6000002-2008-07660
    Event Type
    Death
    Date Received
    June 18, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P750057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED AFTER AN IMPLANT DURATION OF THREE DAYS, DUE TO UNK REASONS. NO FURTHER DETAILS WERE PROVIDED. IT IS UNK IF PT'S DEATH IS DEVICE RELATED. INFO LEARNED FROM IMPLANT PT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 2700 R-08A0052

    Patients

    Seq Age Sex Outcome Treatment
    1 Death