BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1060311 · Received June 12, 2008

    Report

    Report Number
    6000002-2008-07549
    Event Type
    Death
    Date Received
    June 12, 2008
    Date of Event
    April 11, 2008
    Report Date
    May 14, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED IN 2008 DUE TO UNKNOWN REASONS. IMPLANT DURATION 11 DAYS. IT IS UNKNOWN IF PATIENT'S DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 3000TFX R-08A0131

    Patients

    Seq Age Sex Outcome Treatment
    1 Death