BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT FLEXSTAR XL BILIARY STENT

    MDR report key: 1239968 · Received November 21, 2008

    Report

    Report Number
    9681442-2008-00181
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 1, 2008
    Report Date
    November 3, 2008
    Manufacturer
    ANGIOMED GMBH & CO.
    Product Code
    FGE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED, AS THIS PRODUCT IS THE SAME OR SIMILAR TO A DEVICE 510(K) K060487, CURRENTLY DISTRIBUTED IN THE U.S. THE STENT REMAINS IMPLANTED, THEREFORE, NO SAMPLE EVALUATION COULD BE DONE. THE EVENT IS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RETURNED TO THE EMERGENCY ROOM WITH ACUTE ISCHEMIA 3 DAYS AFTER AN ANGIOPLASTY OF A STENT USED FOR RECANALIZATION OF THE KNEE. DIAGNOSIS: STENT THROMBOSIS WITH DOUBLE FRACTURE. PATIENT RECEIVED FEMORO-POPLITEAL BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR XL BILIARY STENT FGE ANGIOMED GMBH & CO. 58514465

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention