BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT BILIARY STENT SYSTEM

    MDR report key: 2240854 · Received August 5, 2011

    Report

    Report Number
    9681442-2011-00044
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    FGE
    PMA / PMN Number
    K053404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE SAMPLE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL TO DATE. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RESISTANCE WAS OBSERVED DURING DEPLOYMENT OF A BILIARY STENT. REPORTEDLY, WHILE USING THE THUMBWHEEL TO DEPLOY THE STENT, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN CONTINUED TO FORCEFULLY TURN THE THUMBWHEEL TO COMPLETE DEPLOYMENT. THE DELIVERY SYSTEM WAS THEN RETRACTED THROUGH THE INTRODUCER SHEATH, AND IT WAS OBSERVED THAT APPROX HALF OF THE STENT WAS WITHDRAWN FROM THE PT AND REMAINED WITHIN THE INTRODUCER SHEATH. THE PT IS REPORTED TO BE ASYMPTOMATIC AND IMAGING DEMONSTRATED SUITABLE PATENCY OF THE TREATMENT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT BILIARY STENT SYSTEM FGE ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANUD3114

    Patients

    Seq Age Sex Outcome Treatment
    1