BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM

    MDR report key: 1843825 · Received September 10, 2010

    Report

    Report Number
    9681442-2010-00084
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 19, 2010
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIP
    PMA / PMN Number
    P070014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 AND THE DELIVERY SYSTEM WAS DISCARDED BY USER FACILITY; THEREFORE, IT IS NOT AVAILABLE FOR EVAL. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT FORESHORTENED. THE PHYSICIAN DEPLOYED THE STENT IN THE MID-DISTAL SFA WITHOUT ANY DIFFICULTY. HOWEVER, UPON DEPLOYMENT THE STENT LENGTH WAS 100 MM INSTEAD OF 170 MM. THE PHYSICIAN DEPLOYED ANOTHER STENT TO SUCCESSFULLY TREAT THE LESION. 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. MEDIZINTECHNIK ANUG0915

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR