BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1202891 · Received October 16, 2008

    Report

    Report Number
    6000002-2008-08963
    Event Type
    Death
    Date Received
    October 16, 2008
    Date of Event
    August 3, 2008
    Report Date
    October 2, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS EXPIRED APPROXIMATELY AFTER IMPLANT DURATION OF 0.01 MONTHS DUE TO RENAL FAILURE. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL #3000TFX, WAS IMPLANTED. REFER TO MFR #6000002-2008-08962. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 6900PTFX R08G1410

    Patients

    Seq Age Sex Outcome Treatment
    1 Death