BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMASHIELD GOD WOVEN D.V. AORTIC ARCH VA

    MDR report key: 397095 · Received May 29, 2002

    Report

    Report Number
    6000072-2002-00017
    Event Type
    Death
    Date Received
    May 29, 2002
    Date of Event
    April 27, 2002
    Report Date
    May 2, 2002
    Manufacturer
    BOSTON SCIENTIFIC WAYNE
    Product Code
    DSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR CLAIMS THAT TWO DAYS AFTER THE GRAFT SUCCESSFULLY IMPLANTED IN 2002, FOR AN AORTIC ARCH REPLACEMENT, THE PATIENT SUDDENLY DEVELOPED A HIGH DEGREE OF DRAINAGE AND A DECREASE IN BLOOD PRESSURE. ACCORDING TO THE DR, THE PATIENT WAS IMMEDIATELY RE-OPENED BY THORACIC DIVISION. THE IMPLANTED GRAFT WAS THEN FOUND TO BE COLLAPSED AND HAVING A HOLE IN ITS PROXIMAL PORTION. THE HOLE WAS APPROXIMATELY 5MM IN DIAMETER, LOCATED SEVERAL CENTIMETERS FROM THE SUTURES PLACED DURING THE INITIAL SURGERY AND WAS INDEPENDENT OF THOSE SUTURES. THE DOCTOR STITCHED THE HOLE AND APPLIED [GLUE] TO STOP THE BLEEDING. ON THE NEXT MONTH, THE PATIENT EXPIRED. THE DOCTOR CLAIMS THAT THE DEATH WAS DEVICE-RELATED. FIVE DAYS LATER, CO LEARNED THE FOLLOWING: PREFECTURAL POLICE DEPARTMENT OF HYOHGO BROUGHT BACK THE REMOVED GRAFT WITH HEART AND AORTA IN ORDER TO EVALUATE/INVESTIGATE AT THE SCIENCE LABORATORY OF SPECIAL INVESTIGATION. THE PATIENT PREOPERATIVE HEALTH HAD BEEN STEADY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD GOD WOVEN D.V. AORTIC ARCH VA SEALED VASCULAR GRAFT DSY BOSTON SCIENTIFIC WAYNE 175924 4657698

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| H| L