BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNISCIENCE CARDIAC VALVE PROSTHESIS

    MDR report key: 378957 · Received February 25, 2002

    Report

    Report Number
    2124529-2002-00002
    Event Type
    Death
    Date Received
    February 25, 2002
    Date of Event
    July 18, 1999
    Report Date
    February 21, 2002
    Manufacturer
    MEDICALCV, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO A RECENTLY-RECEIVED COURT DOCUMENT, IN WHICH THE COMPANY WAS NAMED AS A RESPONDENT IN DISCOVERY, THIS PATIENT UNDERWENT MITRAL VALVE REPLACEMENT IN 1999 DUE TO VALVULAR STENOSIS AND REGURGITATION. FOUR MONTHS LATER, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH TACHYCARDIA, PANSYSTOLIC MURMUR, HYPOTENSION, AND DETERIORATING CONDITION. AUTOPSY FOUND LARGE, FRIABLE VEGETATIONS IN THE LATERAL WALL OF THE LEFT ATRIUM, EXTENDING INTO THE PROSTHETIC VALVE AND BLOCKING 2/3 OF THE ORIFICE. MICROSCOPIC EVIDENCE OF MILD, CHRONIC INFLAMMATION IN THE ENDOCARDIUM AND ISCHEMIC CHANGES OF THE MYOCARDIUM WERE SEEN. THE AUTOPSY REPORT STATES THE PRIMARY CAUSE OF DEATH WAS ENDOCARDITIS, WITH THROMBI IN THE LEFT ATRIUM AND PROSTHETIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNISCIENCE CARDIAC VALVE PROSTHESIS MECHANICAL HEART VALVE LWQ MEDICALCV, INC. 6522 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death| H| L