BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1201387 · Received October 17, 2008

    Report

    Report Number
    6000002-2008-08969
    Event Type
    Death
    Date Received
    October 17, 2008
    Date of Event
    September 26, 2008
    Report Date
    October 14, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 DAYS, DUE TO VENTRICULAR RUPTURE. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL #6900PTFX, WAS EXPLANTED. REFER TO MFR# 6000002-2008-08971. 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 PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 6900PTFX R08G1534

    Patients

    Seq Age Sex Outcome Treatment
    1 Death