BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1242315 · Received November 20, 2008

    Report

    Report Number
    6000002-2008-09312
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    August 4, 2008
    Report Date
    September 23, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE WAS EXPLANTED AT IMPLANT. IN 2008 SURGEON'S OFFICE RESPONSE INDICATES EXPLANT, DUE TO MITRAL REGURGITATION. DEVICE IS NOT AVAILABLE FOR RETURN DUE TO VALVULAR ENDOCARDITIS, UNK SOURCE.

    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 R08G1433

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention