BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS-EXTENDED SEWING RI

    MDR report key: 1082099 · Received July 22, 2008

    Report

    Report Number
    6000002-2008-53700
    Event Type
    Death
    Date Received
    July 22, 2008
    Date of Event
    April 13, 2008
    Report Date
    May 27, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P870077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN. [SEE SCANNED PAGE.]

    Description of Event or Problem · 1

    REPORTEDLY, THE PT EXPIRED IN 2008 AFTER 16 DAYS OF IMPLANT DURATION, DUE TO UNK REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS-EXTENDED SEWING RI REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 6625 R-08A0013

    Patients

    Seq Age Sex Outcome Treatment
    1 Death