BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM

    MDR report key: 1386597 · Received March 17, 2009

    Report

    Report Number
    9681442-2009-00032
    Event Type
    Malfunction
    Date Received
    March 17, 2009
    Date of Event
    February 24, 2009
    Report Date
    February 24, 2009
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED, AS THIS PRODUCT IS THE SAME OR SIMILAR TO A DEVICE PMA P070014 CURRENTLY DISTRIBUTED IN THE U.S. THE STENT REMAINS IMPLANTED, THEREFORE NO EVAL COULD BE DONE. THE INVESTIGATION OF THE EVENT IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT MEASURED 80MM POST DEPLOYMENT. THERE WAS AN APPROX. 40% SHRINKAGE (STENT FORESHORTENING). THE VESSEL DIAMETER WAS 5MM. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK 58556878

    Patients

    Seq Age Sex Outcome Treatment
    1