BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1163063 · Received September 15, 2008

    Report

    Report Number
    6000002-2008-08636
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 14, 2008
    Report Date
    September 4, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED APPROXIMATELY AFTER AN IMPLANT DURATION OF 3 MONTHS, DUE TO ENDOCARDITIS, SEVERE PARAVALVULAR LEAK, AND PULMONARY EDOMA.

    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 R-08C0532

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention