BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S.M.A.R.T. CONTROL NITINOL STENT TRANSHEPTATIC BILIARY

    MDR report key: 1153484 · Received September 8, 2008

    Report

    Report Number
    MW5008239
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 8, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON ATTEMPT OF INITIAL STENT - DEMONSTRATED FAILURE TO DEPLOY. THE STENT WAS REMOVED IN ITS ENTIRETY AND A NEW STENT WAS PLACED. NO HARM TO PATIENT. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: RADIOLOGIC PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S.M.A.R.T. CONTROL NITINOL STENT TRANSHEPTATIC BILIARY TRANSHEPATIC BILIARY STENT FGE CORDIS CORPORATION 13222433

    Patients

    Seq Age Sex Outcome Treatment
    1