BEUDAMED
    FDA Adverse Event Death Summary report: N

    BJORK-SHILEY 60 DEGREE CONVEXO-CONCAVE

    MDR report key: 74711 · Received March 7, 1997

    Report

    Report Number
    6000012-1997-00011
    Event Type
    Death
    Date Received
    March 7, 1997
    Date of Event
    September 4, 1996
    Report Date
    February 19, 1997
    Manufacturer
    SHILEY INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION H3&H6-DEVICE EVALUATION SUMMARY: THE VALVE WAS EXAMINED WITH A LIGHT MICROSCOPE AT 10X-40X MAGNIFICATION AND A FRACTOGRAPHIC ANALYSIS WAS DONE. ACCORDING TO THE VALVE EXAMINATION REPORT, THE FRACTOGRAPHIC FAILURE ANALYSIS CONCLUDED THAT THE LEFT LEG FAILED FIRST. PROPAGATION WAS BY FATIGUE FOR BOTH THE RIGHT AND LEFT OUTLET STRUT LEGS. THERE WAS 95% BURNISHING ON THE LEFT OUTLET STROUT FACE AND LESS THAN 5% BURNISHING ON THE RIGHT OUTLET STRUT FACE.CRACK ORIGIN WAS ON THE INFLOW SIDE AT THE 6 O'CLOCK POSITION FOR BOTH THE LEFT AND RIGHT OUTLET STRUT LEGS. ACCORDING TO THE REPORT, "THE ROOT CAUSE WAS DUE TO FATIGUE AT THE INITIATION SITES FOR BOTH LEGS". WEAR PATTERNS, SCRATCHES, AND INSTRUMENT MARKS TYPICAL FOR A VALVE IMPLANTED FOR 14 YEARS WERE OBSERVED ON THE FLANGE INNER DIAMETER, RIMS, OUTLET STRUT, AND INLET STRUT. THE FRACTOGRAPHIC FAILURE ANALYSIS INDICATED THAT 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 REPORTER, THE PT DIED FOLLOWING OUTLET STRUT FRACTURE OF HIS IMPLANTED HEART VALVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death