BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1085744 · Received July 30, 2008

    Report

    Report Number
    6000002-2008-08287
    Event Type
    Death
    Date Received
    July 30, 2008
    Date of Event
    August 21, 2007
    Report Date
    October 11, 2007
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ATRIAL VENTRICULAR DEHISCENCE-VENTRICULAR RUPTURE.

    Description of Event or Problem · 1

    REPORTEDLY THE DEVICE WAS EXPLANTED AT IMPLANT DATE 2007. THE PT EXPIRED SHORTLY AFTER SURGERY. PLEASE ALSO REFERENCE IMPLANTED DEVICE 6900PTFX SIZE 27, ON MFR REPORT #6000008-2008-08288.

    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 R-07F1274

    Patients

    Seq Age Sex Outcome Treatment
    1 Death