BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR XL BILIARY STENT

    MDR report key: 1213225 · Received October 22, 2008

    Report

    Report Number
    9681442-2008-00162
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    FGE
    PMA / PMN Number
    K060487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS BEING REPORTED BECAUSE THE DEVICE IS THE SAME OR SIMILAR TO ONE THAT IS MARKETED IN THE UNITED STATES. THE COMPLAINT SAMPLE HAS BEEN RECEIVED AT THE MANUFACTURING SITE AND IS CURRENTLY BEING EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PLACEMENT, THE CATHETER SHAFT BROKE OFF AT THE POINT WHERE THE STENT ENDED. THE DETACHED PART REMAINED IN THE SHEATH AND THE DOCTOR WAS ABLE TO REMOVE IT FROM THE SHEATH. NO REPORTED INJURY TO THE PT. NO EXCESSIVE FORCE USED TO PULL ON THE SYSTEM AFTER PLACEMENT OF THE STENT. THIS WAS FOR AN SFA PROCEDURE TAKING AN ANTEGRADE APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR XL BILIARY STENT FGE ANGIOMED GMBH & CO. MEDIZINTECHNIK 58515384

    Patients

    Seq Age Sex Outcome Treatment
    1