BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOMEDICS PROSTHETIC HEART VALVE

    MDR report key: 513020 · Received February 26, 2004

    Report

    Report Number
    1627803-2004-00002
    Event Type
    Injury
    Date Received
    February 26, 2004
    Date of Event
    January 15, 2004
    Report Date
    February 26, 2004
    Manufacturer
    CARBOMEDICS, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING HOSPITALIZATION OF THE PT IN 2004, IT WAS DETERMINED THAT ONE LEAFLET OF THE IMPLANTED CARBOMEDICS MITRAL VALVE WAS STUCK CLOSED AND THE OTHER LEAFLET HAD RESTRICTED MOVEMENT. THE VALVE WAS EXPLANTED IN 2004 AND WAS FOUND TO BE COVERED WITH PANNUS TISSUE. THE PT WAS LAST REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARBOMEDICS PROSTHETIC HEART VALVE PROSTHETIC HEART VALVE, MECHANICAL LWQ CARBOMEDICS, INC. 700 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R