BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLSTENT ENTERAL ENDOPROSTHESIS

    MDR report key: 1393063 · Received May 27, 2009

    Report

    Report Number
    3005099803-2008-01688
    Event Type
    Death
    Date Received
    May 27, 2009
    Date of Event
    July 11, 2006
    Report Date
    July 11, 2006
    Manufacturer
    BOSTON SCIENTIFIC IRELAND LTD.
    Product Code
    MQR
    PMA / PMN Number
    K000281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE SHAFT WAS SLIGHTLY BENT AND A PORTION OF THE OUTER SHEATH WAS TWISTED. THE CAUSE OF THE DAMAGE IS UNKNOWN. A FUNCTIONAL EVALUATION REVEALED NO ISSUES. THE CAUSE OF THE REPORTED DIFFICULTY DURING ADVANCING IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PERTINENT LOT WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2006, THAT A WALLSTENT ENTERAL ENDOPROSTHESIS WAS USED DURING A STENT IMPLANT PROCEDURE IN A MALE PATIENT (AGE AND WEIGHT UNKNOWN) ON THE SAME DAY. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE IT WAS "EXTREMELY DIFFICULT" TO CROSS THE LESION WITH THE STENT DELIVERY SYSTEM. "THIS WAS DUE TO THE ADVANCED STATUS OF THE TUMOR. THE STENT IMPLANT WAS MEANT TO AVOID SURGERY INTERVENTION HOWEVER, THE PATIENT WAS TAKEN TO SURGERY AND ONE WEEK LATER DIED DUE TO THE ADVANCED CANCER. THE PHYSICIAN INSISTED ON THE FACT THAT THE CAUSE OF THE FAILED PROCEDURE WAS THE PATIENT DISEASE STATUS." IN ADDITION TO THE PHYSICIAN'S STATEMENT REGARDING THE CAUSE OF DEATH, THIS EVENT WAS REVIEWED BY A MEDICAL DOCTOR WITHIN BOSTON SCIENTIFIC CORPORATION IN THE SAME MONTH; THE BOSTON SCIENTIFIC PHYSICIAN CONCURRED WITH THE PATIENT'S PHYSICIAN THAT THERE WAS NO RELATIONSHIP BETWEEN THE DEVICE AND THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ENTERAL ENDOPROSTHESIS STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC IRELAND LTD. M00565590 8520510

    Patients

    Seq Age Sex Outcome Treatment
    1 Death