BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2312940 · Received October 28, 2011

    Report

    Report Number
    9616099-2011-00817
    Event Type
    Malfunction
    Date Received
    October 28, 2011
    Date of Event
    September 8, 2011
    Report Date
    September 8, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION AND THE ANALYSIS WAS COMPLETED. ONE NON-STERILE PKG ASSY 7X060 SMART VAS120CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. STENT WAS PARTIALLY DEPLOYED 5.0 MM, AND LOCKING PIN WAS IN PLACE. TWO KINKS WERE DETECTED AT 8 CM FROM DISTAL END AND 1.5 CM FROM PROXIMAL END. NO OTHER DISCREPANCIES WERE FOUND. THE OUTER DIAMETER (OD) OF THE OUTER SHEATH WAS MEASURED AT DIFFERENT DISTANCES AND FOUND WITHIN SPECIFICATION. DEPLOYMENT PROCESS WAS COMPLETED PER DP 12189826 REV. 1 AND NO RESISTANCE WAS FOUND. THE SDS WAS INTRODUCED INTO A LAB SAMPLE FR6 CSI INTRODUCER PER DP 12155483 REV. 1 WITH NO RESISTANCE FOUND. 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 CAUSE, OF "KINKS" CONDITION COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. CONTROLS ARE IN PLACED AT THE FINAL ASSEMBLY AND PACKAGING PROCESSES TO DETECT THIS KIND OF ISSUES "MWI 10182201 REV.22 100% FINAL INSPECTION". HANDLING AND PROCEDURAL FACTORS COULD BE CONTRIBUTED TO THIS CONDITION. THE FAILURE REPORTED "FAILURE TO CROSS" BY THE CUSTOMER COULD NOT BE CONFIRMED; SINCE NO ANOMALIES WERE FOUND DURING FUNCTIONAL AND DIMENSIONAL ANALYSES. THE FAILURE REPORTED "DEPLOYMENT DIFFICULTY-PREMATURE DEPLOYMENT" BY THE CUSTOMER WAS CONFIRMED. THE CAUSE OF THIS CONDITION COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. CONTROLS ARE IN PLACED AT THE FINAL ASSEMBLY AND PACKAGING PROCESS TO DETECT THESE KINDS OF ISSUES "MWI 10182201 REV.22 100% FINAL INSPECTION". NEITHER THE DHR REVIEW NOR THE ANALYSIS SUGGESTS THAT THE FAILURE IS MANUFACTURING PROCESS. THEREFORE NO ACTIONS WERE TAKEN.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE SDS WOULD NOT CROSS THE LESION. THE LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION. VESSEL/LESION CHARACTERISTICS WERE UNKNOWN. THE USER HELD THE HANDLE OF THE SMART CONTROL STENT DELIVERY SYSTEM (SDS) FLAT AND STRAIGHT OUTSIDE THE PATIENT AS INSTRUCTED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. ANALYSIS OF THE RETURNED DEVICE NOTED PARTIAL PRE-MATURE DEPLOYMENT OF THE STENT. ONE NON-STERILE PKG ASSY 7X060 SMART VAS 120 CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. STENT WAS PARTIALLY DEPLOYED 5.0 MM, AND LOCKING PIN WAS IN PLACE. TWO KINKS WERE DETECTED AT 8 CM FROM DISTAL END AND 1.5 CM FROM PROXIMAL END. NO OTHER DISCREPANCIES WERE FOUND. THE OUTER DIAMETER (OD) OF THE OUTER SHEATH WAS MEASURED AT DIFFERENT DISTANCES AND FOUND WITHIN SPECIFICATION. DEPLOYMENT PROCESS WAS COMPLETED PER DP (B)(4) AND NO RESISTANCE WAS FOUND. THE SDS WAS INTRODUCED INTO A LAB SAMPLE FR6 CSI INTRODUCER PER (B)(4) WITH NO RESISTANCE FOUND. 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 CAUSE OF "KINKS" CONDITION COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. CONTROLS ARE IN PLACED AT THE FINAL ASSEMBLY AND PACKAGING PROCESSES TO DETECT THIS KIND OF ISSUES "(B)(4) 100% FINAL INSPECTION". HANDLING AND PROCEDURAL FACTORS COULD BE CONTRIBUTED TO THIS CONDITION. THE FAILURE REPORTED "FAILURE TO CROSS" BY THE CUSTOMER COULD NOT BE CONFIRMED; SINCE NO ANOMALIES WERE FOUND DURING FUNCTIONAL AND DIMENSIONAL ANALYSES. THE FAILURE REPORTED "DEPLOYMENT DIFFICULTY-PREMATURE DEPLOYMENT" BY THE CUSTOMER WAS CONFIRMED. THE CAUSE OF THIS CONDITION COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. CONTROLS ARE IN PLACED AT THE FINAL ASSEMBLY AND PACKAGING PROCESS TO DETECT THESE KINDS OF ISSUES "(B)(4) 100% FINAL INSPECTION". NEITHER THE DHR REVIEW NOR THE ANALYSIS SUGGESTS THAT THE FAILURE IS MANUFACTURING PROCESS. THEREFORE NO ACTIONS WERE TAKEN. IT IS UNKNOWN IF UNUSUAL FORCE WAS USED IN THE ATTEMPT TO CROSS THE LESION AS PUSHING THE SDS AGAINST RESISTANCE, WHICH CAN BE ENCOUNTERED DURING SDS ADVANCEMENT THROUGH CALCIFIED, TORTUOUS, OR STENOTIC VASCULATURE, CAN CAUSE THE OUTER MEMBER TO COMPRESS, THUS CONTRIBUTING TO PREMATURE STENT DEPLOYMENT/STENT JUMPING WHILE THE LOCKING PIN IS STILL IN. THE IFU STATES, "IF RESISTANCE IS MET DURING DELIVERY INTRODUCTION, THE SYSTEM SHOULD BE WITHDRAWN AND ANOTHER SYSTEM SHOULD BE USED." VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING USE IN THE PATIENT, THERE WAS CROSSING DIFFICULTY WITH THE SMART CONTROL. THE PRODUCT WAS RETURNED FOR ANALYSIS. VESSEL/LESION CHARACTERISTICS WERE UNKNOWN. THE PATIENT WAS FINE AFTER THE PROCEDURE. THERE WAS NO PATIENT INJURY. PRODUCT ANALYSIS REPORTED PREMATURE DEPLOYMENT OF THE STENT OF ABOUT 5.0MM; THEREFORE, THE COMPLAINT WILL BE SUBMITTED AS A REPORTABLE PRODUCT MALFUNCTION. THE QUALRAP REPORTED THAT IT WAS UNKNOWN WHEN THE PREMATURE STENT DEPLOYMENT OCCURRED. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION. THE USER HELD THE HANDLE OF THE SMART CONTROL STENT DELIVERY SYSTEM (SDS) FLAT AND STRAIGHT OUTSIDE THE PATIENT AS INSTRUCTED IN THE INSTRUCTIONS FOR USE (IFU). NO FURTHER INFORMATION WAS AVAILABLE.

    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 15274329

    Patients

    Seq Age Sex Outcome Treatment
    1