BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOMEDICS PROSTHETIC HEART VALVE

    MDR report key: 485946 · Received September 26, 2003

    Report

    Report Number
    1627803-2003-00005
    Event Type
    Injury
    Date Received
    September 26, 2003
    Date of Event
    August 19, 2003
    Report Date
    September 26, 2003
    Manufacturer
    CARBOMEDICS, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A MITRAL CPHV WAS EXPLANTED AND REPLACED THREE YEARS POST IMPLANT DUE TO THROMBOSIS. THE VALVE WAS IMPLANTED IN 2000. IN 2003 THE PT PRESENTED WITH CLINICAL SYMPTOMS. THE VALVE WAS THEN EXPLANTED ONE MONTH LATER AND REPLACED WITH ANOTHER CARBOMEDICS CPHV MITRAL VALVE. AT REOPERATION THE SURGEON FOUND DARK THROMBOSIS ADHERED TO THE VALVE. 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 C415336-F

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R