BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM

    MDR report key: 1439820 · Received June 5, 2009

    Report

    Report Number
    9681442-2009-00061
    Event Type
    Malfunction
    Date Received
    June 5, 2009
    Report Date
    May 15, 2009
    Manufacturer
    ANGIOMED GMBH & CO.
    Product Code
    NIP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 EVENT INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN INTRODUCING THE DELIVERY CATHETER INTO THE INTRODUCER SHEATH, THE STENT WAS PARTIALLY RELEASED. THE PHYSICIAN WAS ABLE TO REMOVE THE DELIVERY SYSTEM AND HE HAD TO USE ANOTHER ONE TO CONTINUE THE PROCEDURE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. 58499234

    Patients

    Seq Age Sex Outcome Treatment
    1