BEUDAMED
    FDA Adverse Event Death Summary report: N

    POLYFLEX ESOPHAGEAL STENT

    MDR report key: 1031584 · Received March 20, 2008

    Report

    Report Number
    3005099803-2008-00284
    Event Type
    Death
    Date Received
    March 20, 2008
    Date of Event
    February 19, 2008
    Report Date
    February 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ESW
    PMA / PMN Number
    K012752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT IS UNDETERMINED. THE FEBRUARY 2008 15-MONTH POLYFLEX ESOPHAGEAL STENT PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. THE DIRECTIONS FOR USE STATES: "VITAL SIGNS SHOULD BE MONITORED...DURING THE FIRST 24 HOURS." HOWEVER, THE PT WAS SENT HOME WITHIN 12 HOURS FOLLOWING THE PROCEDURE AND IT WAS NOT CONFIRMED IF THE PT'S VITAL SIGNS WERE MONITORED DURING THIS INTERVAL. THE CAUSE OF DEATH AND/OR AUTOPSY RESULTS WERE NOT MADE AVAILABLE TO BOSTON SCIENTIFIC CORP.

    Description of Event or Problem · 1

    A POLYFLEX ESOPHAGEAL STENT WAS USED DURING A STENT PLACEMENT PROCEDURE IN A MALE PT IN 2008. ACCORDING TO THE COMPLAINANT, " [T] HE PROCEDURE WAS COMPLETED WITH NO APPARENT PROBLEMS, AND THE PT WAS SENT HOME WITH NO PAIN AND NORMAL BREATHING. APPROXIMATELY 12 HOURS LATER, THE PT EXPERIENCED TROUBLE BREATHING AND A AMBULANCE WAS CALLED TO THE PT'S HOME. THEY WERE UNABLE TO REVIVE THE PT AND THE PT WAS PRONOUNCED DEAD AT THE SCENE. IT IS UNKNOWN AT THIS TIME IF THE BSC STENT WAS DIRECTLY OR INDIRECTLY RESPONSIBLE FOR THE PT'S DEATH." DESPITE FIVE ATTEMPTS BETWEEN THE ORIGINAL MONTH AND THE FOLLOWING MONTH TO ASCERTAIN DETAILS REGARDING THE EVENT, NO FURTHER INFO WAS MADE AVAILABLE TO BOSTON SCIENTIFIC CORP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLEX ESOPHAGEAL STENT ESW BOSTON SCIENTIFIC CORPORATION M00514300 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Death