BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT FLEXSTAR XL BILIARY STENT

    MDR report key: 1183877 · Received October 1, 2008

    Report

    Report Number
    9681442-2008-00153
    Event Type
    Injury
    Date Received
    October 1, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 1, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    FGE
    PMA / PMN Number
    K060487
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 SAMPLE REMAINS IMPLANTED. WITH THE INFO REC'D TO DATE, THE RESULT OF THE INVESTIGATION IS INCONCLUSIVE AND THE ROOT CAUSE IS UNK. THIS IS THE SAME PT AS MFR REPORT# 9681442-08-00151, -00148.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 STENTS WERE IMPLANTED INTO A PT FOR SFA STENTING APPROX 3 MONTHS AGO. RECENTLY, IT WAS DISCOVERED THAT THE BLOOD FLOW WAS NOT THAT GOOD. AFTER AN X-RAY, IT WAS FOUND THAT THERE WAS THROMBOSIS WITHIN THE STENT AND THERE WERE SOME FRACTURES ALONG CERTAIN SECTIONS OF THE 3 STENTS. THERE WAS A VERY BAD FRACTURE ON THE MIDDLE STENT WHICH IS THE SITE OF THE ORIGINAL STENOSIS. THE DR TRIED TO SALVAGE BY DOING AN ANGIOPLASTY AND HE DID MANAGE TO RESTORE FLOW TO THE STENTS BUT WAS UNSURE HOW LONG THIS WOULD LAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR XL BILIARY STENT FGE ANGIOMED GMBH & CO. MEDIZINTECHNIK KG 58490908

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention