BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR XL BILIARY STENT

    MDR report key: 1371987 · Received February 20, 2009

    Report

    Report Number
    9681442-2009-00013
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    December 22, 2008
    Report Date
    January 28, 2009
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    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 US. THE REVIEW OF THE MANUFACTURING RECORDS SHOW THAT NO REMARKABLE INCIDENTS OCCURRED. THE DEVICE HAS BEEN RETURNED. THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT HAS BEEN IMPLANTED IN THE SFA WITHOUT PROBLEMS. AT THE TIME TO REMOVE THE SYSTEM FROM THE INTRODUCER, IT WAS OBSERVED THAT THE DISTAL TIP APPEARED TO BE DESTROYED; TORN OFF. THE DEVICE WAS REMOVED FROM THE PT AND IT WAS VERIFIED THAT NO MATERIAL REMAINED IN THE PT. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR XL BILIARY STENT FGE ANGIOMED GMBH & CO. MEDIZINTECHNIK 5828148

    Patients

    Seq Age Sex Outcome Treatment
    1