BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOMEDICS PROSTHETIC HEART VALVE

    MDR report key: 486844 · Received October 3, 2003

    Report

    Report Number
    1627803-2003-00006
    Event Type
    Injury
    Date Received
    October 3, 2003
    Date of Event
    September 5, 2003
    Report Date
    October 3, 2003
    Manufacturer
    CARBOMEDICS, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SIZE 19 TOP HAT VALVE WAS REPORTED TO HAVE COME OFF THE HOLDER PRIOR TO IMPLANTATION OF THE VALVE. THE SURGEON ELECTED TO IMPLANT THE VALVE WITHOUT THE HOLDER AND SEWED IT UPSIDE DOWN. HE DISCOVERED THE PROBLEM, EXPLANTED THAT VALVE AND REPLACED IT WITH ANOTHER CARBOMEDICS. THE REPLACEMENT WAS SUCCESSFUL. THE PT IS SAID TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARBOMEDICS PROSTHETIC HEART VALVE SUPRA-ANNULAR, AORTIC VALVE LWQ CARBOMEDICS, INC. S500 A538075-H

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Life Threatening