BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT FLEXSTAR XLVASCULAR STENT SYSTEM

    MDR report key: 1667614 · Received April 23, 2010

    Report

    Report Number
    9681442-2010-00032
    Event Type
    Injury
    Date Received
    April 23, 2010
    Date of Event
    March 22, 2010
    Report Date
    March 29, 2010
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MFG AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECS PRIOR TO SHIPMENT. THE DELIVERY SYSTEM HAS BEEN RETURNED FOR EVAL. THE INVESTIGATION IS CURRENTLY UNDERWAY. THIS EVENT IS BEING REPORTED, BECAUSE THIS DEVICE IS THE SAME OF SIMILAR TO ONE MARKETED IN THE UNITED STATES PMA# P070014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE (ILIO-FEMORAL ENDARTERECTOMY AND RIGHT FEMORAL SUPERFICIAL RECANALIZATION), THE PHYSICIAN ENCOUNTERED DIFFICULTIES DURING THE STENT DEPLOYMENT. A PORTION OF THE STENT WAS RELEASED AND ANOTHER WAS STILL IN THE DELIVERY SYSTEM. THE STENT WAS DEPLOYED, HOWEVER, WAS STRETCHED. THE PHYSICIAN ATTEMPTED BALLOON DILATATION, BUT THE RESULT WAS NOT SATISFACTORY. A PROSTHETIC BYPASS WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR XLVASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK ANTA0940

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention