BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1050145 · Received May 19, 2008

    Report

    Report Number
    6000002-2008-07261
    Event Type
    Death
    Date Received
    May 19, 2008
    Report Date
    April 17, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED AFTER AN IMPLANT DURATION OF ONE MO DUE TO UNK REASON. NO FURTHER INFO WAS PROVIDED. INFO LEARNED FROM IMPLANT PT 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