BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPRO

    MDR report key: 1212068 · Received October 23, 2008

    Report

    Report Number
    6000002-2008-09040
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    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

    IT WAS REPORTED THE DEVICE WAS EXPLANTED AT IMPLANT DUE TO 2+ MITRAL REGURGITATION OBSERVED WITH CENTRAL JET. REPORTEDLY, THE DEVICE WAS REPLACED WITH A MEDTRONIC MOSAIC MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPRO REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 7000TFX R-08G1533

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention