BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLSTENT BILIARY ENDOPROSTHESIS

    MDR report key: 2180064 · Received July 27, 2011

    Report

    Report Number
    3005099803-2011-02561
    Event Type
    Death
    Date Received
    July 27, 2011
    Date of Event
    May 19, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K000308
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - STENT BLOCKED/OCCLUDED. THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY ENDOPROSTHESIS WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE UNDER SEDATION IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THERE WERE NO PROBLEMS REPORTED DURING THE INITIAL STENT PLACEMENT, WHICH WAS PLACED FOR ALLEVIATION OF SYMPTOMS FROM A NON-RESECTABLE MALIGNANT BILIARY STRICTURE. ON (B)(6) 2011 THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND WAS REPORTED IN VERY POOR GENERAL CONDITION. THE PATIENT HAD JAUNDICE AND AN ELEVATED BILIRUBIN LEVEL OF 310, INDICATING INSUFFICIENT BILIARY DRAINAGE. THIS WAS CLASSIFIED AS STENT FAILURE. NO INTERVENTION WAS PERFORMED, AND THE PATIENT DIED ON (B)(6) 2011. THE PHYSICIAN REPORTED THE CAUSE OF DEATH AS CANCER DISEASE PROGRESSION. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT BILIARY ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H965431100 0013406385

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death| H