BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT FLEXSTAR XL BILIARY STENT

    MDR report key: 1243784 · Received November 24, 2008

    Report

    Report Number
    9681442-2008-00185
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 11, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    FGE
    PMA / PMN Number
    K060487
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE NOT REVIEWED, AS THE LOT NUMBER IS UNKNOWN. THE STENT REMAINS IMPLANTED, THEREFORE, NO SAMPLE EVALUATION COULD BE DONE. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BILIARY STENTS IMPLANTED IN THE SFA, ALLEGEDLY FRACTURED. THREE STENTS WERE PLACED SIX MONTHS AGO. REPORTEDLY, FRACTURES ARE SEEN AT TWO POINTS. THE PATIENT HAS HAD PAIN AND THE PHYSICIAN FOUND THAT THE PROXIMAL END OF THE STENT WAS COMPLETELY THROMBOSED. THE PHYSICIAN LINED THE ENTIRE STENT WITH ANOTHER STENT, AND THE PATIENT IS NOW ASYMPTOMATIC. PATIENT INJURY FROM THE FRACTURE IS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention