BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT SOLO VASCULAR STENT SYSTEM

    MDR report key: 3231343 · Received July 15, 2013

    Report

    Report Number
    9681442-2013-00074
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    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. BASED ON THE INVESTIGATION PERFORMED IT IS CONFIRMED THAT THE DEPLOYMENT MECHANISM WAS ACTIVELY USED AND THAT THE DEPLOYMENT MECHANISM BROKE WHEN THE STENT WAS PARTIALLY RELEASED. IT IS ALSO CONFIRMED THAT THE USER THEN UNSUCCESSFULLY TRIED TO COMPLETE THE STENT RELEASE BY OPENING THE GRIP AND DIRECTLY PULLING ON THE GREEN WIRE. THE STENT WAS FOUND FRACTURED WHICH WAS CONSIDERED A RESULT OF THE ATTEMPT TO WITHDRAW THE PARTIALLY RELEASED AND ANCHORED STENT, AS REPORTED. NO INDICATIONS WERE FOUND FOR MANUFACTURING RELATED ISSUES. POTENTIAL FACTORS THAT COULD HAVE LED OR CONTRIBUTED TO THE DEPLOYMENT FAILURE HAVE BEEN EVALUATED. THE EVENT REPORTED MAY BE USE RELATED AS ROUGH HANDLING ESPECIALLY DURING UNPACKING MAY NEED TO DEFORMATION AND SUBSEQUENT RELEASE FORCE INCREASE. IN THIS CASE, KINKS WERE FOUND IN THE PROXIMAL SECTION BUT IT WAS NOT KNOWN WHETHER THESE KINKS WERE CAUSED BEFORE, DURING, OR AFTER THE EVENT REPORTED. BASED ON THE INFORMATION AVAILABLE, A DEFINITE ROOT CAUSE FOR THE EVENT REPORTED COULD NOT BE IDENTIFIED. THE IFU STATES: "DO NOT CONSTRICT THE DELIVERY SYSTEM DURING STENT DEPLOYMENT. IF EXCESSIVE FORCE IS FELT DURING STENT DEPLOYMENT, DO NOT FORCE THE STENT SYSTEM. REMOVE THE STENT SYSTEM AND REPLACE WITH A NEW UNIT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE VASCULAR STENT DEPLOYMENT IN THE SFA, THE VASCULAR STENT PARTIALLY DEPLOYED, ADDITIONAL EFFORTS MADE TO COMPLETE THE DEPLOYMENT WERE UNSUCCESSFUL. THEREFORE, THE CATHETER USED TO RECAPTURE THE VASCULAR STENT, SHEARED THE VASCULAR STENT OFF FROM THE DELIVERY SYSTEM. THE REMAINING PORTION OF THE VASCULAR STENT AND DELIVERY SYSTEM WERE EXCHANGED OVER THE WIRE AS ONE UNIT FOR A VASCULAR STENT THAT WAS DEPLOYED SUCCESSFULLY, COVERING THE PARTIALLY DEPLOYED VASCULAR STENT AND SFA LESION. THERE IS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327659 LIFESTENT SOLO VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXC2727

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention