BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1933846 · Received December 21, 2010

    Report

    Report Number
    9616099-2010-01011
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING AN INTERVENTIONAL PROCEDURE THE SMART CONTROL HAD RESISTANCE / FRICTION WITH THE OUTER SHEATH AND THE STENT HAD DEPLOYMENT DIFFICULTY WITH PARTIAL DEPLOYMENT. THE PATIENT WAS MALE BUT AGE WAS UNKNOWN. THE TARGET LESION WAS SUPERFICIAL FEMORAL ARTERY. THE VESSEL WAS MODERATELY CALCIFIED AND MILDLY TORTUOUS; THE RATE OF STENOSIS WAS 70%. A SMART CONTROL (COMPLAINT PRODUCT) WAS DELIVERED OVER A 0.035 RADIFOCUS GUIDEWIRE (TERUMO) TO THE TARGET LESION. HOWEVER, FRICTION/RESISTANCE OCCURRED WITH THE OUTER SHEATH DURING THE STENT DEPLOYMENT. THE SDS WAS REMOVED FROM THE PATIENT AND EXCHANGED TO OTHER NEW PRODUCT (DETAILS UNK). THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER ISSUES. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. WHEN THE PRODUCT WAS RECEIVED FOR EVALUATION IT WAS NOTICED THAT THE STENT WAS PROTRUDING 2.5CM FROM THE TIP OF THE DELIVERY SYSTEM. FOLLOW UP REVEALED THAT DURING THE PROCEDURE THE STENT DEPLOYMENT WAS STOPPED AT THE MIDDLE OF THE DEPLOYMENT AS THE FRICTION/RESISTANCE HAD OCCURRED WITH THE OUTER SHEATH. ONE NON STERILE UNIT OF SMART CONTROL 7X40 MM WAS RECEIVED COILED IN A PLASTIC BAG, LOCKING PIN WAS IN PLACE AND STENT WAS RECEIVED FULLY DEPLOYED IN THE SAME BAG. OUTER SHEATH WAS PARTIALLY SEPARATED AT 6.7 CM FROM ID BAND. NO OTHER DISCREPANCIES WERE FOUND. OUTER DIAMETER (OD) OF THE STENT DELIVERY SYSTEM WAS MEASURED AT SEVERAL LOCATIONS AND IT WAS FOUND WITHIN SPECIFICATION. THE DEPLOYMENT PROCESS WAS PERFORMED WITHOUT THE STENT, RESISTANCE WAS FELT AT THE PARTIALLY SEPARATED OUTER SHEATH LOCATION FOUND DURING VISUAL ANALYSIS; HOWEVER IT WAS POSSIBLE TO DEPLOY AND RETRACT THE WIRE LUMEN. A 0.035" LAB SAMPLE GUIDEWIRE WAS INTRODUCED FROM DISTAL END AND RESISTANCE WAS FELT AT THE SAME LOCATION; HOWEVER THE WIRE WENT THOUGH. THE STENT DELIVERY SYSTEM (SDS) WAS INTRODUCED INTO A LAB SAMPLE 6FR CSI INTRODUCER AND RESISTANCE WAS FOUND AT THE PARTIALLY SEPARATED LOCATION; HOWEVER THE CSI WENT THROUGH THE ENTIRE LENGTH OF THE SDS. 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 'PARTIAL DEPLOYMENT' CONDITION REPORTED BY THE CUSTOMER WAS NOT CONFIRMED SINCE THE STENT WAS RECEIVED FULLY DEPLOYED. THE 'RESISTANCE /FRICTION-OUTER SHEATH' CONDITION, REPORTED BY THE CUSTOMER WAS CONFIRMED, SINCE RESISTANCE WAS FELT AT THE PARTIALLY DEPLOYED LOCATION FOUND DURING VISUAL ANALYSIS. THE CAUSE OF THE PARTIAL SEPARATION COULD NOT BE DETERMINED; HOWEVER IT DOES NOT APPEAR TO BE MANUFACTURING RELATED, CONTROLS EXIST IN THE MANUFACTURING PROCESS TO PREVENT THIS TYPE OF CONDITION. HANDLING AND THE COILED CONDITION OF THE UNIT RECEIVED FOR ANALYSIS MAY CONTRIBUTE TO THE FAILURE AS FOUND. THE CAUSE OF THE BENT CONDITION OF THE OUTER SHEATH, FOUND DURING THE PRODUCT ANALYSIS, COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER IT COULD BE RELATED TO THE COILED CONDITION OF THE PRODUCT RECEIVED FOR ANALYSIS. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE PRODUCT; THEREFORE, NO CORRECTIVE / PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE 'PARTIAL DEPLOYMENT' CONDITION REPORTED BY THE CUSTOMER WAS NOT CONFIRMED SINCE THE STENT WAS RECEIVED FULLY DEPLOYED. THE 'RESISTANCE /FRICTION-OUTER SHEATH' CONDITION, REPORTED BY THE CUSTOMER WAS CONFIRMED, SINCE RESISTANCE WAS FELT AT THE PARTIALLY DEPLOYED LOCATION FOUND DURING VISUAL ANALYSIS. THE CAUSE OF THE PARTIAL SEPARATION COULD NOT BE DETERMINED; HOWEVER IT DOES NOT APPEAR TO BE MANUFACTURING RELATED, CONTROLS EXIST IN THE MANUFACTURING PROCESS TO PREVENT THIS TYPE OF CONDITION. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS PER THE AFFILIATE, FRICTION/RESISTANCE OCCURRED WITH THE OUTER SHEATH DURING THE STENT DEPLOYMENT. WHEN THE PRODUCT WAS RECEIVED FOR EVALUATION IT WAS NOTICED THAT THE STENT WAS PROTRUDING 2.5CM FROM THE TIP OF THE DELIVERY SYSTEM. FOLLOW UP REVEALED THAT DURING THE PROCEDURE THE STENT DEPLOYMENT WAS STOPPED AT THE MIDDLE OF THE DEPLOYMENT AS THE FRICTION/RESISTANCE WAS OCCURRED WITH THE OUTER SHEATH. THE PATIENT WAS MALE BUT AGE WAS UNKNOWN. THE TARGET LESION WAS SUPERFICIAL FEMORAL ARTERY. THE VESSEL WAS MODERATELY CALCIFIED AND MILDLY TORTUOUS; THE RATE OF STENOSIS WAS 70%. A SMART CONTROL (COMPLAINT PRODUCT) WAS DELIVERED OVER A 0.035 RADIFOCUS GUIDEWIRE (TERUMO) TO THE TARGET LESION. HOWEVER, FRICTION/RESISTANCE OCCURRED WITH THE OUTER SHEATH DURING THE STENT DEPLOYMENT . THE SDS WAS REMOVED FROM THE PATIENT AND EXCHANGED TO OTHER NEW PRODUCT (DETAILS UNK). THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER ISSUES. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION.

    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 NA 15083575

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO GUIDEWIRE