BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIPROSTHESIS

    MDR report key: 1080827 · Received July 21, 2008

    Report

    Report Number
    6000002-2008-08123
    Event Type
    Death
    Date Received
    July 21, 2008
    Date of Event
    June 3, 2008
    Report Date
    July 8, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE. MODEL # 4600, WAS IMPLANTED. REFER TO MFR REPORT # 6000002-2008-08121. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS EXPIRED AFTER AN IMPLANT DURATION OF 4 DAYS, DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. PT ALSO HAD ANOTHER DEVICE IMPLANTED ON THE SAME DAY. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 3000TFX R-07M2373

    Patients

    Seq Age Sex Outcome Treatment
    1 Death