BEUDAMED
    FDA Adverse Event Death Summary report: N

    BJORK-SHILEY 60 DEGREE CONVEXO-CONCAVE

    MDR report key: 981367 · Received January 15, 2008

    Report

    Report Number
    6000012-2007-00013
    Event Type
    Death
    Date Received
    January 15, 2008
    Date of Event
    November 27, 2007
    Report Date
    December 19, 2007
    Manufacturer
    SHILEY, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS EXAMINED WITH A LIGHT MICROSCOPE AT 20X MAGNIFICATION. THE RIGHT LEG OF THE OUTLET STRUT WAS FOUND TO HAVE SEPARATED FROM THE VALVE FLANGE (TERMED A "SINGLE LEG SEPARATION"). THE LEFT LEG OF THE OUTLET STRUT WAS FOUND TO BE INTACT. ACCORDING TO THE VALVE EXAMINATION REPORT, WEAR PATTERNS, SCRATCHES, AND INSTRUMENT MARKS TYPICAL FOR VALVES IMPLANTED FOR PERIODS GREATER THAN 25 YEARS WERE NOTED ON THE OUTLET STRUT, INLET STRUT, FLANGE INNER DIAMETER, RIMS, AND DISC.

    Description of Event or Problem · 1

    THE PT CONTACTED SHILEY TO REPORT THAT HIS BJORK-SHILEY CONVEXO-CONCAVE AORTIC AND MITRAL VALVES WOULD BE ELECTIVELY REPLACED AND REQUESTED TO HAVE THE VALVES RETURNED FOR EXAMINATION. MICROSCOPIC EXAMINATION REVEALED A SINGLE LEG SEPARATION OF THE RIGHT OUTLET STRUT LEG OF THE MITRAL VALVE. SUBSEQUENTLY, SHILEY WAS NOTIFIED THAT THE PT DIED 7 DAYS FOLLOWING VALVE REPLACEMENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BJORK-SHILEY 60 DEGREE CONVEXO-CONCAVE HEART VALVE LWQ SHILEY, INC. 29MBRC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death| H (STOP'D)| BJORK-SHILEY 60 DEGREE CONVEXO-CONCAVE AORTIC