BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM

    MDR report key: 1473923 · Received May 11, 2009

    Report

    Report Number
    9681442-2009-00051
    Event Type
    Malfunction
    Date Received
    May 11, 2009
    Date of Event
    April 16, 2009
    Report Date
    April 16, 2009
    Manufacturer
    ANGIOMED GMBH & CO.
    Product Code
    NIP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO ONE MARKETED IN THE UNITED STATES PMA#P070014. THE DEVICE REMAINS IMPLANTED; THEREFORE, NOT AVAILABLE. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE STENT WAS DEPLOYED, IT ONLY MEASURED 5 CM IN LENGTH INSTEAD OF 7MM. THE PROBLEM WAS IDENTIFIED AFTER THE STENT WAS DEPLOYED, A SECOND STENT WAS REQUIRED TO BE DEPLOYED AS A RESULT. THE PATIENT'S CURRENT CONDITION IS UNKNOWN; HOWEVER, ADDITIONAL EVENT INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. 58347611

    Patients

    Seq Age Sex Outcome Treatment
    1