BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR XL BILIARY STENT

    MDR report key: 1170524 · Received September 11, 2008

    Report

    Report Number
    9681442-2008-00145
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 12, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    FGE
    PMA / PMN Number
    K060487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO ONE THAT IS MARKETED IN THE UNITED STATES. THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOW THAT NO REMARKABLE INCIDENTS OCCURRED. THE SAMPLE HAS BEEN RETURNED AND THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLACK OUTER CATHETER ON THE DELIVERY SYSTEM SNAPPED AS IT WAS BEING INSERTED INTO THE PT. ALTHOUGH THE CONSULTANT COMMENTED THAT IT MUST HAVE BEEN IN THE PT WHEN IT SNAPPED. IT DID NOT EFFECT THE DEPLOYMENT OF THE STENT. NO REPORTED INJURY TO THE PT. THE PROCEDURE WAS STENTING THE SFA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR XL BILIARY STENT FGE ANGIOMED GMBH & CO. MEDIZINTECHNIK 58488870

    Patients

    Seq Age Sex Outcome Treatment
    1