BEUDAMED
    FDA Adverse Event Death Summary report: N

    BJORK-SHILEY 60 DEGREE CONVEXO-CONCAVE VALVE

    MDR report key: 1728353 · Received June 14, 2010

    Report

    Report Number
    6000012-2010-00001
    Event Type
    Death
    Date Received
    June 14, 2010
    Date of Event
    December 8, 2009
    Report Date
    June 15, 2010
    Manufacturer
    SHILEY, LLC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH REPORT WAS RECEIVED FROM THE USER FACILITY.

    Description of Event or Problem · 1

    SHILEY RECEIVED A REPORT FROM COUNSEL FOR THE PATIENT WHO ADVISED SHILEY OF THE DEATH OF A PATIENT FOLLOWING AN ALLEGED OUTLET STRUT FRACTURE OF THE PATIENT'S BJORK-SHILEY CONVEXO-CONCAVE AORTIC HEART VALVE. WE HAVE REQUESTED ADDITIONAL INFORMATION REGARDING THE ALLEGED ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BJORK-SHILEY 60 DEGREE CONVEXO-CONCAVE VALVE HEART VALVE LWQ SHILEY, LLC. 25ABC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death| H