BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2021483 · Received March 17, 2011

    Report

    Report Number
    9616099-2011-00185
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 18, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K042969
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING AN INTERVENTIONAL PROCEDURE THE SMART CONTROL STENT WAS AN INCORRECT LENGTH, TOO SHORT. DESPITE MULTIPLE REQUESTS, TO DATE THERE ARE NO PATIENT, VESSEL, LESION OR PROCEDURAL DETAILS AVAILABLE. IT WAS REPORTED THAT AFTER DEPLOYMENT THE STENT FOR-SHORTENED. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. THE STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND: REVIEW OF LOT 15294146 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15294146. THE STENT SIZE AND LOTS PROVIDED AS WELL AS THE QUANTITY OF STENT UNITS PROVIDED AND RELEASED WERE REVIEWED AND NO ANOMALIES WERE FOUND. RIVETED STENT 12 X 80MM LOTS 15287221, 15272394 AND 15274078 WERE REVIEWED. IT WAS OBSERVED DURING REVIEW OF THESE LOTS THAT NO NONCONFORMANCES WERE GENERATED, AND NO INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. 1 UNIT WAS REJECTED DUE TUBE PEEL DURING THE ASSEMBLY OF LOT 15287221, 2 UNITS WERE REJECTED DUE TUBE PEEL DURING THE ASSEMBLY OF LOT 15272394 AND NO UNITS WERE REJECTED DURING THE ASSEMBLY OF LOT 15274078. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE RECEIVING INSPECTION RECORDS FOR THE EXPANDED STENT 12 X 80MM LOTS 201011020135, 201010280057, 201010250024 AND 201010270145 WERE REVIEWED, AND THESE LOTS WERE DEEMED ACCEPTABLE. REVIEW OF THE LOTS 15294147 AND 15294149 MANUFACTURED BEFORE AND AFTER COMPLAINT LOT, REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 2 UNITS WERE REJECTED DUE DAMAGED OUTER MEMBER DURING THE FINAL ASSEMBLY LOT 15294147 AND NO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY LOT 15294149. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT OR PROCEDURAL FILMS AVAILABLE FOR ANALYSIS THE COMPLAINT COULD NOT BE CONFIRMED. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY AND THE DHR REVIEW CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT BASED ON THE LIMITED INFORMATION AVAILABLE. THE SMART CONTROL IFU STATES, "4. SLACK REMOVAL A. ADVANCE THE STENT DELIVERY SYSTEM PAST THE LESION SITE. B. PULL BACK THE STENT DELIVERY SYSTEM UNTIL THE RADIOPAQUE STENT MARKERS (LEADING AND TRAILING ENDS) MOVE IN POSITION SO THAT THEY ARE PROXIMAL AND DISTAL TO THE LESION SITE. C. ENSURE THAT THE STENT DELIVERY SYSTEM OUTSIDE THE PATIENT REMAINS FLAT AND STRAIGHT. CAUTION: SLACK IN THE CATHETER SHAFT EITHER OUTSIDE OR INSIDE THE PATIENT MAY RESULT IN DEPLOYING THE STENT BEYOND THE LESION SITE. 5. STENT DEPLOYMENT: A. VERIFY THAT THE DELIVERY SYSTEM'S RADIOPAQUE STENT MARKERS (LEADING AND TRAILING ENDS) ARE PROXIMAL AND DISTAL TO THE TARGET LESION. B. ENSURE THAT THE INTRODUCER SHEATH DOES NOT MOVE DURING DEPLOYMENT. C. REMOVE LOCKING PIN FROM HANDLE. D. INITIATE ONE-HANDED STENT DEPLOYMENT BY ROTATING THE TUNING DIAL WITH THUMB AND INDEX FINGERS IN A CLOCKWISE DIRECTION (DIRECTION OF ARROW) WHILE HOLDING THE HANDLE IN A FIXED POSITION. E. WHILE USING FLUOROSCOPY, MAINTAIN POSITION OF THE RADIOPAQUE STENT MARKERS RELATIVE TO THE TARGETED LESION SITE. WATCH FOR THE DISTAL RADIOPAQUE MARKERS TO BEGIN SEPARATING. SEPARATION OF THE DISTAL STENT MARKERS SIGNALS THAT THE STENT IS UNSHEATHED. CONTINUE TURNING THE TUNING DIAL UNTIL THE DISTAL END OF THE STENT OBTAINS FULL APPOSITION WITH THE VESSEL WALL. NOTE: ONLY THE INITIAL 40 MM OF THE STENT MAY BE UNSHEATHED USING THE TUNING DIAL. F. WITH MAINTAINING A FIXED HANDLE POSITION, PULL BACK THE DEPLOYMENT LEVER TO UNSHEATHE THE REMAINDER OF THE STENT. NOTE: FAILURE TO MAINTAIN A FIXED HANDLE POSITION OR CONSTRAINING THE CATHETER SHAFT DURING DEPLOYMENT MAY RESULT IN STENT COMPRESSION (SHORTENING) OR ELONGATION. NOTE: THE STENT MAY BE DEPLOYED USING TWO HANDS ("PIN AND PULL" METHOD) BY HOLDING THE PROXIMAL END OF THE HANDLE STATIONARY WITH ONE HAND AND SLIDING THE DEPLOYMENT LEVER BACK TOWARDS THE STATIONARY HAND G. STENT DEPLOYMENT IS COMPLETE WHEN THE PROXIMAL MARKERS APPOSE TO THE VESSEL WALL AND THE OUTER SHEATH RADIOPAQUE MARKER IS PROXIMAL TO THE INNER SHAFT STENT STOP."

    Description of Event or Problem · 1

    A SMART CONTROL STENT STENT FOR-SHORTENED AFTER DEPLOYMENT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA 15294146

    Patients

    Seq Age Sex Outcome Treatment
    1