BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1081698 · Received July 22, 2008

    Report

    Report Number
    6000002-2008-08125
    Event Type
    Death
    Date Received
    July 22, 2008
    Date of Event
    October 29, 2007
    Report Date
    January 30, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 2007, SAME DAY OF THE IMPLANT SURGERY DUE TO UNKNOWN REASONS. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL #6900P, WAS EXPLANTED. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL #3000TFX, WAS EXPLANTED. REFER TO MFR #6000002-2008-08122. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death