BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM

    MDR report key: 1380858 · Received March 20, 2009

    Report

    Report Number
    9681442-2009-00035
    Event Type
    Malfunction
    Date Received
    March 20, 2009
    Date of Event
    February 24, 2009
    Report Date
    February 24, 2009
    Manufacturer
    ANGIOMED GMBH & CO.
    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 EVALUATION COULD BE DONE. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY. THIS EVENT INVOLVES TWO DEVICES WITH THE SAME MALFUNCTION AND IS THE SAME PATIENT AS REPORTED UNDER MANUFACTURER REPORT NO 9681442-2009-00032.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT MEASURED 45MM POST DEPLOYMENT; THERE WAS AN APPROX 25% SHRINKAGE. THE VESSEL DIAMETER WAS 5-6MM. THERE WAS NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. 58419047

    Patients

    Seq Age Sex Outcome Treatment
    1