BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM

    MDR report key: 1830164 · Received September 3, 2010

    Report

    Report Number
    9681442-2010-00082
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 5, 2010
    Manufacturer
    ANGIOMED GMBH & CO.
    Product Code
    NIP
    PMA / PMN Number
    P070014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 EVALUATION. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY. THIS EVENT INVOLVES TWO DEVICES USED IN THE PATIENT. THEREFORE, THIS EVENT IS ALSO ASSOCIATED WITH THE EVENT REPORTED UNDER MANUFACTURER REPORT NO 9681442-2010-00083.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO STENTS FORESHORTENED. REPORTEDLY, THE PHYSICIAN SUCCESSFULLY DEPLOYED A 170MM STENT AND A 100MM STENT IN THE RIGHT MID SFA. AFTER DEPLOYMENT, IT WAS IDENTIFIED THAT THE STENTS HAD FORESHORTENED. THE 170MM STENT FORESHORTENED APPROXIMATELY 6 TO 7 CM AND THE 100MM STENT HAD FORESHORTENED 3 TO 4 CM. THE LESION WAS NOT FULLY TREATED; HOWEVER, THE PHYSICIAN DECIDED NOT TO DEPLOY ANOTHER STENT. THERE WAS NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. ANUE3272

    Patients

    Seq Age Sex Outcome Treatment
    1