BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILER BILIARY STENT

    MDR report key: 611171 · Received May 25, 2005

    Report

    Report Number
    1037905-2005-00060
    Event Type
    Malfunction
    Date Received
    May 25, 2005
    Date of Event
    May 3, 2005
    Report Date
    May 9, 2005
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN USED A WILSON-COOK ZILVER BILIARY STENT DURING AN ERCP PROCEDURE. TH STENT WAS ADVANCED INTO THE LEFT HEPATIC STRICTURE. ONCE IN PLACE THE STENT PARTIALLY DEPLOYED. AN ATTEMPT TO FULLY DEPLOY THE STENT FALLED. THE INTRODUCTION SYSTEM AND THE PARTIALLY DEPLOYED STENT WERE REMOVED. DURING REMOVAL THE STENT SEPARATED AND A SMALL PORTION OF THE STENT REMAINED IN THE PT'S DUCT. ANOTHER STENT WAS PLACED THE NEXT DAY. NO INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZILER BILIARY STENT METAL BILIARY STENTS FGE WILSON-COOK MEDICAL, INC. NA W1891415

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR