BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1852871 · Received October 5, 2010

    Report

    Report Number
    9616099-2010-00753
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN USING THE TUNING DIAL TO INITIATE DEPLOYMENT OF THE STENT IT WAS REPORTED THAT AFTER EXPOSURE OF APPROXIMATELY 1MM OF THE STENT ,THE DIAL STOPPED ROTATING AND THE STENT DEPLOYMENT STOPPED. THE PHYSICIAN WAS ABLE TO UNSHEATH THE REST OF THE STENT WITHOUT USING THE DIAL AND THE STENT WAS PLACED AT THE TARGET LESION AS INTENDED WITH GOOD RESULTS. THERE WAS NO INJURY TO THE PATIENT. THE DEVICE HAD BEEN PREPPED AND INSPECTED ACCORDING TO INSTRUCTIONS FOR USE. THE DIFFUSELY CALCIFIED, 150MM LEFT SUPERFICIAL FEMORAL ARTERY LESION WAS PRE-DILATED WITH A 5MM BALLOON, AND THE STENT WAS DELIVERED WITHOUT TRACKING OR CROSSING DIFFICULTY. THE LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARD THE LESION AND REMOVED BEFORE ATTEMPTING TO DEPLOY THE STENT. THE STENT DELIVERY SYSTEM WAS ADVANCED PAST THE LESION AND WITHDRAWN BACK INTO THE LESION PRIOR TO STENT DEPLOYMENT. THE HANDLE WAS HELD FLAT AND STRAIGHT OUTSIDE OF THE PATIENT'S BODY. NO UNUSUAL FORCE WAS APPLIED DURING DEPLOYMENT. INSPECTION OF THE RETURNED DEVICE SHOWED THAT IT OPERATED CORRECTLY. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN RELATED TO PROCEDURAL FACTORS, VESSEL CHARACTERISTICS AND/OR USER HANDLING AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE. ONE NON STERILE UNIT OF SMART CONTROL 10 X 60 MM WAS RECEIVED COILED IN A PLASTIC BAG. LOCKING PIN AND STENT WERE NOT RECEIVED. OUTER SHEATH WAS KINK AT 1.5CM AND 6.5 CM. IT WAS VERIFIED THAT THE OUTER SHEATH WAS PROPERLY CONNECTED TO THE SLIDER. NO OTHER ANOMALIES WERE FOUND. USABLE LENGTH WAS MEASURED AND WAS FOUND TO BE WITHIN SPECIFICATION. OUTER SHEATH LENGTH WAS MEASURED AND WAS WITHIN SPECIFICATION. THE DEPLOYMENT PROCESS WAS PERFORMED WITHOUT THE STENT. THE FUNCTIONAL ANALYSIS WAS PERFORMED PER IFU. THE DEPLOYMENT PROCESS STARTED DURING INITIAL ROTATION, AND THE TUNING DIAL WAS ROTATED 25 TIMES WITH NO RESISTANCE AND THEN STOPPED. IT WAS NOT POSSIBLE TO ROTATE THE DIAL FURTHER BECAUSE THE LENGTH OF THE STENT IS 60 MM; USING THE TUNING DIAL ONLY 50 MM APPROXIMATELY ARE DEPLOYED, THEREFORE THE DEPLOYMENT LEVER MOVEMENT MUST BE PERFORMED TO RELEASE THE REST OF THE STENT. THE DEPLOYMENT PROCESS WAS COMPLETED SUCCESSFULLY, NO RESISTANCE WAS FELT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE "ROTATION DIFFICULTY" CONDITION REPORTED BY THE CUSTOMER WAS NOT CONFIRMED SINCE NO RESISTANCE WAS FELT ON TUNING THE DIAL DURING DEPLOYMENT PROCESS. THE "DEPLOYMENT DIFFICULTY-PARTIAL DEPLOYMENT" CONDITION WAS NOT CONFIRMED, SINCE NO ANOMALIES WERE FOUND DURING THE DEPLOYMENT PROCESS. THE FAILURE DOES NOT APPEAR TO BE MANUFACTURING RELATED. CONTROLS EXIST IN THE FINAL ASSEMBLY AND PACKAGING PROCESSES TO PREVENT THIS TYPE OF FAILURE, AS WELL AS THERE ARE INSPECTIONS IN PLACE TO DETECT THEM IN THE SDS. PROCEDURAL FACTORS AND HANDLING MAY CONTRIBUTE TO FAILURE AS REPORTED. THE KINKED/BENT CONDITION FOUND DURING VISUAL ANALYSIS COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER IT COULD BE RELATED TO THE COILED CONDITION OF THE UNIT RECEIVED FOR ANALYSIS. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGEST THAT THE CONDITION REPORTED BY THE CUSTOMER COULD BE MANUFACTURING RELATED, THEREFORE NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR ANALYSIS, BUT THE ANALYSIS HAS NOT YET BEEN COMPLETED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT.ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ABLE TO DILATE AND EXPOSE AT LEAST 1MM OF THE STENT WHEN THE DIAL STOPPED ROTATING AND THE STENT WAS NO LONGER ABLE TO BE EXPOSED. HE WAS, HOWEVER, ABLE TO UNSHEATH THE REST OF THE STENT WITHOUT USING THE DIAL AND THE STENT WAS PLACED AT THE TARGET LESION AS INTENDED WITH GOOD RESULTS. THERE WAS NO INJURY TO THE PATIENT. THE DEVICE HAD BEEN PREPPED AND INSPECTED ACCORDING TO INSTRUCTIONS FOR USE. THE DIFFUSELY CALCIFIED, 150MM LEFT SUPERFICIAL FEMORAL ARTERY LESION WAS PRE-DILATED WITH A 5MM BALLOON, AND THE STENT WAS DELIVERED WITHOUT TRACKING OR CROSSING DIFFICULTY. THE LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARD THE LESION AND REMOVED BEFORE ATTEMPTING TO DEPLOY THE STENT. THE STENT DELIVERY SYSTEM WAS ADVANCED PAST THE LESION AND WITHDRAWN BACK INTO THE LESION PRIOR TO STENT DEPLOYMENT. THE HANDLE WAS HELD FLAT AND STRAIGHT OUTSIDE OF THE PATIENT'S BODY. NO UNUSUAL FORCE WAS APPLIED DURING DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIO) NIO CORDIS DE MEXICO 15201252

    Patients

    Seq Age Sex Outcome Treatment
    1