BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1062385 · Received June 18, 2008

    Report

    Report Number
    3005099803-2008-00759
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    February 28, 2008
    Report Date
    June 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK; THEREFORE, THE MFR DATE CANNOT BE DETERMINED. NOTE: THE EVENT, AS REPORTED, DID NOT REFLECT A MDR-REPORTABLE SCENARIO; HOWEVER, EVAL OF THE RETURNED DEVICE, WHICH WAS COMPLETED ON JUNE 4, 2008, REVEALED A MDR-REPORTABLE MALFUNCTION. THIS MFR REPORT IS BASED ON THE EVAL RESULTS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FULLY MOUNTED AND THAT THE OUTER SHEATH WAS RETRACTED 9 MM FROM THE TIP. SEVERAL STENT WIRES HAD PERFORATED THE OUTER SHEATH (SEE FIGURE 1, PAGE 3). IN ADDITION, THE INNER LUMEN WAS KINKED AT THE GUIDEWIRE EXIT POINT. A FUNCTIONAL EXAMINATION REVEALED THAT THE OUTER SHEATH OF THE DELIVERY SYSTEM COULD NOT BE RETRACTED AND THE SHAFT WAS BROKEN PROXIMAL TO THE GUIDEWIRE ACCESS POINT. THE CAUSE OF THE MALFUNCTION IS UNK.

    Description of Event or Problem · 1

    NOTE: THIS REPORT ADDRESSES ONE OF TWO DEVICES USED DURING THE PROCEDURE. REFER TO MFR REPORT # 3005099803-2008-00480 FOR A DESCRIPTION OF THE RELATED DEVICE. A WALLSTENT RX BILIARY ENDOPROSTHESIS WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN AN ADULT FEMALE PT (AGE AND WEIGHT UNK) IN 2008. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN ATTEMPTED TO DEPLOY A WALLSTENT RX BILIARY ENDOPROSTHESIS (THE SUBJECT OF THIS REPORT) AND THE "DELIVERY SYSTEM TWISTED, SO PREVENTING THE STENT FROM BEING RELEASED." THE DELIVERY SYSTEM WAS REMOVED AND THE PHYSICIAN ATTEMPTED TO DEPLOY A SECOND WALLSTENT RX BILIARY ENDOPROSTHESIS. "THE SECOND STENT DEPLOYED" BUT "WHEN THE [PHYSICIAN] TRIED TO REMOVE THE SECOND DELIVERY SYSTEM, IT BROKE INTO TWO PIECES AND ONE PIECE WAS LEFT IN THE PT." IT IS UNK IF THE PIECE WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO IMPLANT A PERCUTANEOUS STENT (NOT BOSTON SCIENTIFIC CORP PRODUCT-MFR UNK). DURING THE PROCEDURE, THE PHYSICIAN PERFORATED THE COMMON BILE DUCT. IT IS NOT KNOWN IF THE PERCUTANEOUS STENT WAS SUCCESSFULLY IMPLANTED. THE PT DEVELOPED PERITONITIS AS A RESULT OF THE PERFORATION, AND A PERCUTANEOUS DRAIN (MFR UNK) WAS PLACED. THE PT "RECOVERED ADEQUATELY TO UNDERGO FURTHER ERCP 6 DAYS LATER." ACCORDING TO INFO RECEIVED ON MARCH 14, 2008, "THE PT REMAINS IN SATISFACTORY CONDITIONS". THE DEVICE HISTORY RECORD (DHR) FOR THE PERTINENT LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THE LOT. AN APRIL 2008 15 MONTH PLACEHIT WALLSTENT BILIARY ENDOPROSTHESIS PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC IRELAND, LTD M00569660 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention