BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT VASCULAR STENT SYSTEM

    MDR report key: 3193546 · Received June 25, 2013

    Report

    Report Number
    9681442-2013-00066
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014/S038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 THE SPECIFICATION PRIOR TO SHIPMENT. NO ADDITIONAL COMPLAINT HAS BEEN PREVIOUSLY REPORTED FOR THIS LOT NUMBER. AS PART OF ALL COMPLAINT INVESTIGATIONS, AN ATTEMPT IS MADE TO EVALUATE THE SUBJECT DEVICE AS WELL AS THE DEVICE USAGE. IN THIS PARTICULAR CASE, NO SAMPLE AND NO IMAGES WERE PROVIDED FOR EVALUATION. A ROOT CAUSE ANALYSIS FOR THIS FAILURE MODE HAS BEEN PERFORMED. THE TWISTING OF THIS KIND OF STENT IS CAUSED BY INTERACTIONS OF VARIOUS USE RELATED AND ANATOMICAL FACTORS WITH THE GIVEN STENT DESIGN. HOWEVER, IN THIS CASE, A DEFINITE ROOT CAUSE FOR THE ISSUE REPORTED COULD NOT BE IDENTIFIED. THE IFU STATES: "INITIATE STENT DEPLOYMENT BY ROTATING THE THUMBWHEEL IN THE DIRECTION OF THE ARROWS WHILE HOLDING THE HANDLE IN A FIXED POSITION.... WHILE MAINTAINING A FIXED HANDLE POSITION, ROTATE THUMBWHEEL TO OBTAIN INITIAL STENT WALL APPOSITION OF 1 CM MINIMUM... WHILE MAINTAINING A FIXED HANDLE POSITION, PLACE YOUR FINGER IN FRONT OF THE DEPLOYMENT SLIDE AND SLIDE IT FROM THE DISTAL TO PROXIMAL END...DEPLOYMENT OF THE STENT IS COMPLETE WHEN THE PROXIMAL STENT END APPOSES THE VESSEL WALL AND THE SHEATH RADIOPAQUE ZONE IS PROXIMAL TO THE PROXIMAL END OF THE STENT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VASCULAR STENT DEPLOYMENT IN AN SFA VESSEL, THE VASCULAR STENT BECAME TWISTED DURING THE DEPLOYMENT; THEREFORE, A PTA BALLOON WAS USED TO CREATE AN OPENING BETWEEN THE VASCULAR STENT IN THE VESSEL WALL FOR A BALLOON EXPANDABLE STENT TO BE DEPLOYED SUCCESSFULLY, PUSHING THE VASCULAR STENT AGAINST THE SFA WALL. THE PT WAS REPORTED TO BE ASYMPTOMATIC FOLLOWING THE PROCEDURE. THERE IS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288219 LIFESTENT VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXB0680

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention