BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2240845 · Received September 9, 2011

    Report

    Report Number
    9616099-2011-00715
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 30, 2011
    Report Date
    August 30, 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 PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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 THE IFU STATES, "IF RESISTANCE IS MET DURING DELIVERY INTRODUCTION, THE SYSTEM SHOULD BE WITHDRAWN AND ANOTHER SYSTEM SHOULD BE USED." 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 SMART CONTROL STENT DELIVERY SYSTEM WAS DELIVERED, BUT INITIALLY FAILED TO CROSS THE TARGET LESION DUE TO THE HEAVY CALCIFICATION AND VESSEL TORTUOSITY. PRE-DILATATION WAS CONDUCTED WITH AN UNKNOWN BALLOON CATHETER AND THE SDS WAS ADVANCED ONCE AGAIN. HOWEVER, IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT HAD PREMATURELY DEPLOYED ABOUT 0.5MM DURING ADVANCEMENT TOWARDS THE LESION SO THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED PLACING ANOTHER PRODUCT IN THE LESION WITHOUT PROBLEM. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. THE TARGET LESION WAS LEFT EXTERNAL ILIAC ARTERY WITH HEAVY CALCIFICATION AND VESSEL TORTUOSITY AND A STENOSIS OF 95%.

    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 15397438

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BALLOON CATHETER