BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1000971 · Received February 18, 2008

    Report

    Report Number
    6000002-2008-06055
    Event Type
    Injury
    Date Received
    February 18, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 6, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, THIS DEVICE WAS EXPLANTED AT IMPLANT DUE TO AFTER COMING OFF PUMP, THE PHYSICIAN NOTED THAT ONE OF THE LEAFLETS WAS NOT MOVING SO THERE WAS MITRAL REGURGITATION AS NOTED ON ECHO.

    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 7B0258

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention