BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM

    MDR report key: 1783360 · Received July 28, 2010

    Report

    Report Number
    9681442-2010-00069
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    June 23, 2010
    Report Date
    July 1, 2010
    Manufacturer
    ANGIOMED GMBH & CO
    Product Code
    NIP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THE STENT REMAINS IMPLANTED; THEREFORE, IT IS NOT AVAILABLE FOR EVALUATION. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY. THIS EVENT INVOLVES TWO DEVICES AND IS ASSOCIATED WITH THE PATIENT IN THE EVENT REPORTED UNDER MANUFACTURER REPORT NO 9681442-2010-00068. THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO THE ONE MARKETED IN THE UNITED STATES PMA#: P070014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST PLACEMENT OF TWO STENTS IN THE SFA,THE PATIENT WAS ADMITTED TO THE HOSPITAL. UPON EVALUATION, IT WAS IDENTIFIED THAT THE SFA WAS OCCLUDED AND THE STENT HAD FRACTURED IN SEVERAL PLACES. FEMORAL-DISTAL BYPASS SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO ANSI1882

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R