BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM

    MDR report key: 1455463 · Received May 27, 2009

    Report

    Report Number
    9681442-2009-00057
    Event Type
    Malfunction
    Date Received
    May 27, 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 US PMA#: P070014. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ADVANCING THE DELIVERY CATHETER THROUGH THE SFA STENOSIS, THE STENT WAS PARTIALLY RELEASED DESPITE THE SHIPPING LOCK BEING FIXED TO THE HANDLE. THE PHYSICIAN WAS ABLE TO REMOVE THE DELIVERY SYSTEM AND USED ANOTHER ONE TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. 58581985

    Patients

    Seq Age Sex Outcome Treatment
    1