BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1165323 · Received September 18, 2008

    Report

    Report Number
    3005099803-2008-04674
    Event Type
    Death
    Date Received
    September 18, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    FGE
    PMA / PMN Number
    K102752
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP (BSC) IN 2008, THAT A WALLSTENT RX BILIARY ENDOPROSTHESIS WAS USED DURING A STENT PLACEMENT PROCEDURE EIGHT DAYS PRIOR, (FEMALE PT; WEIGHT UNK). ACCORDING TO THE COMPLAINANT, AFTER STENT DEPLOYMENT, FLUOROSCOPIC IMAGING INDICATED THAT THE LENGTH OF THE STENT DID NOT APPEAR TO REFLECT THE MEASUREMENTS ON THE DEVICE LABEL AND DFU. FLUOROSCOPIC IMAGES HAVE BEEN REQUESTED BY BOSTON SCIENTIFIC CORP, AND HAVE NOT YET BEEN REC'D. IN ADDITION, THE COMPLAINANT REPORTED THAT PT DIED DURING THE PROCEDURE. AN AUTOPSY WAS CONDUCTED EIGHT DAYS LATER. BSC WAS NOT GIVEN THE RESULTS. THE COMPLAINANT SUMMARIZED THE FINDINGS: "MYOCARDIAL INFARCTION CAUSED THE DEATH OF THE PT. THE AUTOPSY SHOWED NO BLEEDING OR ANOMALIES IN THE AREA OF STENT PLACEMENT." [THE PHYSICIAN'S] CLOSING REMARK WAS THAT THE DEATH OF THE FEMALE PT CANNOT BE LINKED WITH OUR [BSC] PROD AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC IRELAND, LTD. M00569800 11343439

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death