BEUDAMED
    FDA Adverse Event Death Summary report: N

    BJORK-SHILEY 70 DEGREE CONVEXO-CONCAVE

    MDR report key: 146809 · Received January 30, 1998

    Report

    Report Number
    6000012-1998-00007
    Event Type
    Death
    Date Received
    January 30, 1998
    Date of Event
    October 10, 1988
    Report Date
    January 5, 1998
    Manufacturer
    SHILEY INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: THE VALVE WAS EXAMINED WITH A LIGHT MICROSCOPE AT 20X MAGNIFICATION AND A FRACTOGRAPHIC ANALYSIS WAS DONE. THE FRACTOGRAPHIC ANALYSIS CONCLUDED THAT THE RIGHT LEG OF THE OUTLET STRUT FAILED FIRST. PROPAGATION WAS BY FATIGUE FOR BOTH THE RIGHT AND LEFT OUTLET STRUT LEGS. THERE WAS 70% BURNISHING ON THE LEFT OUTLET STRUT FACE. CRACK ORIGIN WAS ON THE INFLOW SIDE AT THE 6:00 POSITION FOR BOTH THE LEFT AND RIGHT OUTLET STRUT LEGS. THE ROOT CAUSE WAS DUE TO FATIGUE AT THE INITIATION SITES FOR BOTH LEGS. WEAR PATTERNS, SCRATCHES, AND INSTRUMENT MARKS TYPICAL FOR CLINICALLY EXPLANTED VALVES WERE OBSERVED ON THE STRUTS, THE FLANGE INNER DIAMETER, RIMS, AND DISC. THE FRACTOGRAPHIC FAILURE ANALYSIS INDICATED NO ANOMALOUS ATTRIBUTES WERE FOUND THAT MIGHT HAVE BEEN RESPONSIBLE FOR THE OUTLET STRUT FRACTURE.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL RPTR, THE PT'S BJORK-SHILEY CONVEXO-CONCAVE MITRAL VALVE WAS FOUND TO HAVE HAD AN OUTLET STRUT FRACTURE AFTER HIS BODY WAS EXHUMED AND AN AUTOPSY WAS PERFORMED. UPON RECEIPT OF THE VALVE AT SHILEY, IT WAS NOTED THAT THE VALVE WAS MISSING THE OUTLET STRUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BJORK-SHILEY 70 DEGREE CONVEXO-CONCAVE HEART VALVE LWQ SHILEY INC. 25MBRCB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death BSCC 70 DEGREE AORTIC HEART VALVE| (UNK TO 10/10/1988 (STOP'D)).