BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2120979 · Received June 13, 2011

    Report

    Report Number
    9616099-2011-00409
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 19, 2011
    Report Date
    July 4, 2011
    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

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THE PRODUCT IS AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    WHILE ADVANCING THE SMART CONTROL STENT DELIVERY SYSTEM (SDS) TO THE SUPERFICIAL FEMORAL ARTERY, THE OUTER SHEATH STARTED TO PULL BACK EXPOSING THE DISTAL PART OF THE STENT. THE TARGET LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY TO THE POPLITEAL ARTERY. THERE WAS HEAVY CALCIFICATION AND MODERATE VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS 100%. ACCESS WAS MADE FROM THE LEFT FEMORAL ARTERY. THE DISTAL SFA WAS PRE-DILATED. THE LOCKING PIN WAS CONFIRMED IN PLACE. THE PHYSICIAN DECIDED TO DEPLOY THE STENT AT THIS PLACE. THE ENTIRE TARGET LESION WAS FULLY COVERED BY AN ADDITIONAL THREE SMART CONTROL STENTS AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY. THE USER HELD THE HANDLE OF THE SMART CONTROL SDS FLAT AND STRAIGHT OUTSIDE THE PATIENT PER IFU. ONE NON-STERILE UNIT OF SMART CONTROL 6X100MM WAS RECEIVED COILED IN A PLASTIC BAG. STENT AND LOCKING PIN WERE NOT RECEIVED. OUTER SHEATH WAS BENT AT INNER DIAMETER BAND. BLOOD RESIDUES WERE OBSERVED AT HANDLE AS WELL AS BRITE TIP WAS FOUND DISLODGE 1.2CM. NO OTHER ANOMALY WAS DETECTED. THE USABLE LENGTH WAS MEASURED USING A CALIBRATED RULER (ID J03549, CAL. DUE DATE 10/9/13), AND IT WAS FOUND TO BE 121.3 CM (47.75") WHICH IS WITHIN SPECIFICATION OF 47.78 +/- 0.5CM PER (B)(4). DEPLOYMENT PROCESS WAS PERFORMED WITHOUT STENT, PER DP (B)(4) AND NO RESISTANCE WAS 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 "DEPLOYMENT DIFFICULTY-PREMATURE/IN PATIENT-DURING ADVANCEMENT" CONDITION REPORTED BY THE CUSTOMER WAS NOT CONFIRMED SINCE THE STENT WAS NOT RECEIVED AND NO DISCREPANCIES WERE FOUND DURING DIMENSIONAL AND FUNCTIONAL ANALYSES. THE CAUSE OF THE BENT CONDITION FOUND DURING THE ANALYSIS COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER IT DOES NOT APPEAR TO MANUFACTURING RELATED, CONTROLS ARE IN PLACED AT THE FINAL ASSEMBLY AND PACKAGING PROCESSES TO PREVENT THIS TYPE OF FAILURE, AS WELL AS THERE ARE INSPECTIONS IN PLACE TO DETECT THEM, REFERENCE PROCEDURES DOCUMENTED IN ROUTE SHEET # (B)(4), HANDLING AND THE COILED CONDITION OF THE UNIT RECEIVED FOR ANALYSIS MAY CONTRIBUTE TO THE BENT CONDITION. NEITHER THE DHR REVIEW NOR THE 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. PUSHING THE SDS AGAINST RESISTANCE CAN CAUSE THE OUTER MEMBER TO COMPRESS, THUS CONTRIBUTING TO PREMATURE STENT DEPLOYMENT/STENT JUMPING WITH THE LOCKING PIN STILL IN. THE IFU STATES, "IF RESISTANCE IS MET DURING DELIVERY INTRODUCTION, THE SYSTEM SHOULD BE WITHDRAWN AND ANOTHER SYSTEM SHOULD BE USED." IN THIS CASE, IT IS POSSIBLE THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER WAS RELATED TO PROCEDURAL FACTORS, VESSEL CHARACTERISTICS AND/OR USER HANDLING.

    Description of Event or Problem · 1

    THE PATIENT WAS FEMALE BUT AGE WAS UNKNOWN. THE TARGET LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY TO THE POPLITEAL ARTERY. THERE WAS HEAVY CALCIFICATION AND MODERATE VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS 100%. ACCESS WAS MADE FROM THE LEFT FEMORAL ARTERY. THE DISTAL SFA WAS PRE-DILATED WITH A JACKAL BC (2X20, SJM). WHILE ADVANCING THE SMART CONTROL STENT (COMPLAINT PRODUCT) TO THE SFA, THE OUTER SHEATH STARTED TO PULL BACK BY ITSELF AND THE DISTAL PART OF THE STENT WAS EXPOSED FROM THE SDS. THE LOCKING PIN WAS CONFIRMED IN PLACE. THE PHYSICIAN DECIDED TO DEPLOY THE STENT AT THIS PLACE. THE ENTIRE TARGET LESION WAS FULLY COVERED BY THREE OTHER SMART CONTROL STENTS AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY. THERE WILL BE PRODUCT RETURN. THE USER HELD THE HANDLE OF THE SMART CONTROL SDS FLAT AND STRAIGHT OUTSIDE THE PATIENT PER IFU.

    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 15350702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention