BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT BILIARY ENDOPROSTHESIS

    MDR report key: 1001249 · Received February 22, 2008

    Report

    Report Number
    3005099803-2008-00194
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    January 22, 2007
    Report Date
    January 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD
    Product Code
    FGE
    PMA / PMN Number
    K896163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED, BUT AN EVAL IS NOT COMPLETE; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT IS UNDETERMINED. A REVIEW OF THE COMPLAINT DATABASE DID NOT REVEAL ANY ADD'L COMPLAINTS REPORTED FOR THIS LOT.

    Description of Event or Problem · 1

    A WALLSTENT BILIARY ENDOPROSTHESIS WAS USED DURING A STENT PLACEMENT PROCEDURE IN FEMALE PT (WEIGHT UNK) IN 2008. ACCORDING TO THE COMPLAINANT, THE STENT WAS NOT VISIBLE DURING FOLLOW-UP X-RAY IMAGING SIX DAYS LATER. LATER" ...THAT DAY THE PT FOUND THE STENT IN [HER] STOOL." THE PHYSICIAN HAD PLANNED TO IMPLANT "...A NON-COVERED BILIARY STENT [THAT MAY] RESIST...MIGRATION..." IT IS UNK, HOWEVER, IF THIS FOLLOW-UP PROCEDURE HAS OCCURRED. THE PT'S CONDITION WAS REPORTED AS "STABLE" FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC IRELAND, LTD H965431100 0009538000

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR