BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1170146 · Received September 11, 2008

    Report

    Report Number
    3005099803-2008-04482
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BILIARY STENTING TREATMENT PROCEDURE, THE DEVICE FAILED TO DEPLOY. THE TARGET LESION WAS IN THE COMMON BILE DUCT (CBD). A 10X80 WALLSTENT RX BILIARY STENT WAS ADVANCED TO THE TARGET LESION, BUT THE SHEATH WOULD NOT RETRACT, AND THE DEVICE WOULD NOT DEPLOY. THE DISTAL TIP OF THE STENT DID NOT PERFORATE THE OUTER SHEATH. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED TYPE OF "10X60 STENT". THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC M00569720 0011403800

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR