BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLSTENT ENTERAL DUODENAL STENT

    MDR report key: 1150168 · Received September 3, 2008

    Report

    Report Number
    3005099803-2008-04283
    Event Type
    Death
    Date Received
    September 3, 2008
    Date of Event
    August 3, 2008
    Report Date
    August 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MQR
    PMA / PMN Number
    K042065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 16 DAYS FOLLOWING PLACEMENT OF AN ENTERAL STENT THE PT EXPIRED. THE WALLSTENT HAD BEEN IMPLANTED IN AN UNSPECIFIED LOCATION IN THE GI TRACT. ONE WEEK POST PROCEDURE, THE PT HAD NOT RESUMED BOWEL MOVEMENTS. DURING A RECTAL EXAM, THE NURSE'S FINGER "GOT HOOKED ON SOMETHING". THE PT WAS TRANSPORTED TO THE HOSP FOR AN ABDOMINAL X-RAY WHICH SHOWED THE STENT HAD "BROKEN UP." THE PT WAS TRANSFERRED TO A NURSING HOME AND EXPIRED 16 DAYS POST PROCEDURE. IT WAS REPORTED THAT AN AUTOPSY AND CORONER'S INQUEST WERE PERFORMED. IT WAS FURTHER REPORTED THAT THE AUTOPSY REPORT SHOWED THAT THE PT'S DEATH WAS NOT DUE TO THE DEVICE. ADDITIONAL INFO REGARDING THE DEVICE AND AUTOPSY HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ENTERAL DUODENAL STENT MQR - ENTERAL ENDOPROSTHESIS MQR BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| H