BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLACEHIT WALLSTENT BILIARY ENDOPROSTHESIS

    MDR report key: 1052654 · Received May 22, 2008

    Report

    Report Number
    3005099803-2008-00527
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    March 18, 2008
    Report Date
    May 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC, IRELAND, LTD.
    Product Code
    FGE
    PMA / PMN Number
    K911292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT, AS REPORTED, DID NOT REFLECT A MDR- REPORTABLE SCENARIO; HOWEVER, EVAL OF THE RETURNED DEVICE, WHICH WAS COMPLETED ON MAY 15, 2008, REVEALED A REPORTABLE MALFUNCTION. THIS MANUFACTURER REPORT IS SUBMITTED BASED ON THE EVAL RESULTS. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE CONNECTOR SEPARATED FROM THE OUTER SHEATH. IN ADDITION, SEVERAL STENT WIRES HAD PERFORATED THE OUTER SHEATH. THE STENT WIRES WERE DAMAGED AS A RESULT OF THE PERFORATION THROUGH THE OUTER SHEATH (SEE FIGURE 1, PAGE 3). THE CAUSE OF THE PERFORATION IS UNKNOWN. A FUNCTIONAL EXAMINATION INDICATED THAT IT WAS NOT POSSIBLE TO RETRACT THE OUTER SHEATH.

    Description of Event or Problem · 1

    A PLACEHIT WALLSTENT BILIARY ENDOPROSTHESIS WAS USED DURING A STENT PLACEMENT PROCEDURE ON A FEMALE IN 2008. ACCORDING TO THE COMPLAINANT, THE STENT ONLY DEPLOYED APPROXIMATELY ONE CENTIMETER. WHEN AN ATTEMPT WAS MADE TO RECONSTRAIN THE STENT, RESISTANCE WAS FELT AND TWO STENT WIRES WERE FOUND TO BE PROTRUDING THROUGH THE DISTAL PART OF THE DEVICE. A THIRD ATTEMPT TO RECONSTRAIN THE STENT CAUSED THE DELIVERY SYSTEM TO BREAK. THE STENT WAS REMOVED THROUGH THE DUODENOSCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PLACEHIT WALLSTENT BILIARY ENDOPROSTHESIS. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLACEHIT WALLSTENT BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC, IRELAND, LTD. H965SCH650810 0008987120

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR