BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT FLEXSTAR XL BILIARY STENT

    MDR report key: 1243783 · Received November 24, 2008

    Report

    Report Number
    9681442-2008-00184
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    November 13, 2008
    Report Date
    November 13, 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 A BILIARY STENT IMPLANTED IN THE MID SFA, ALLEGEDLY FRACTURED AND AN INDUCED SYMPTOMATIC STENOSIS. THE STENT WAS PLACED LESS THAN SIX MONTHS AGO. THE PHYSICIAN RELINED THE STENT WITH ANOTHER STENT. THE PATIENT IS NOT ASYMPTOMATIC.

    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