BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR XL BILIARY STENT

    MDR report key: 1236913 · Received November 5, 2008

    Report

    Report Number
    9681442-2008-00170
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Report Date
    October 8, 2008
    Manufacturer
    ANGIOMED GMBH & CO.
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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 SAMPLE HAS BEEN RETURNED AND THE EVALUATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT APPEARS THAT A 80MM STENT WAS IN THE PACKAGING. AFTER RELEASE AND IMPLANT, THE STENT WAS POSTDILATED WITH A BALLOON OF 60 MM IN LENGTH. THE STENT ON THE X-RAY WAS DEFINITELY LONGER. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR XL BILIARY STENT FGE ANGIOMED GMBH & CO. 58509883

    Patients

    Seq Age Sex Outcome Treatment
    1