BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2222097 · Received August 24, 2011

    Report

    Report Number
    9616099-2011-00669
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS ADMITTED WITH A 50% STENOSIS IN THE SUPERFICIAL FEMORAL ARTERY. THE LESION HAD HEAVY CALCIFICATION AND MILD VESSEL TORTUOSITY. A SMART CONTROL WAS ADVANCED FOR DIRECT STENTING. HOWEVER, THE SDS STOPPED ADVANCING ON THE WAY TO THE TARGET LESION. WHEN THE SDS WAS PUSHED WITH EXTRA FORCE, THE DISTAL END OF THE STENT WAS STARTED TO RELEASE A LITTLE. AN INTERNAL CORDIS INVESTIGATION REVEALED THAT 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 THE IFU STATES, "IF RESISTANCE IS MET DURING DELIVERY INTRODUCTION, THE SYSTEM SHOULD BE WITHDRAWN AND ANOTHER SYSTEM SHOULD BE USED." USAGE OF THE PRODUCT OTHER THAN THAT INDICATED IN THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) MAY INVOLVE ADDITIONAL RISKS NOT DESCRIBED IN THE LABELING. THE SDS WAS REMOVED FROM THE PATIENT AND PRE-DILATATION WAS CONDUCTED WITH A BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. THERE WILL BE NO PRODUCT RETURN. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION. THE USER HELD THE HANDLE OF THE SMART CONTROL SDS FLAT AND STRAIGHT OUTSIDE THE PATIENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND: REVIEW OF LOT 15396790 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS ADMITTED WITH A 50% STENOSIS IN THE SUPERFICIAL FEMORAL ARTERY. THE LESION HAD HEAVY CALCIFICATION AND MILD VESSEL TORTUOSITY. A SMART CONTROL WAS ADVANCED FOR DIRECT STENTING. HOWEVER, THE SDS WAS STOPPED ADVANCING ON THE WAY TO THE TARGET LESION. WHEN THE SDS WAS PUSHED WITH EXTRA FORCE, THE DISTAL END OF THE STENT WAS STARTED TO RELEASE A LITTLE. THE SDS WAS REMOVED FROM THE PATIENT AND PRE-DILATATION WAS CONDUCTED WITH A BALLOON CATHETER OF UNKNOWN BRAND. THE PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT OF UNKNOWN BRAND WITHOUT PROBLEMS. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. THERE WILL BE NO PRODUCT RETURN. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION. THE USER HELD THE HANDLE OF THE SMART CONTROL SDS FLAT AND STRAIGHT OUTSIDE THE PATIENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT.

    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 15396790

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR