BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 3093901 · Received May 6, 2013

    Report

    Report Number
    9616099-2013-00268
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING DEPLOYMENT OF A SMART CONTROL STENT (SES) THE STENT JUMPED APPROXIMATELY 1CM DISTALLY REQUIRING AN ADDITIONAL STENT TO BE PLACED PROXIMALLY. THERE WAS NO REPORTED PATIENT INJURY. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION AND WAS REMOVED BEFORE ATTEMPTING TO DEPLOY THE SMART CONTROL STENT. THE SES WAS ADVANCED PAST THE LESION AND THEN WITHDRAWN BACK INTO THE LESION PRIOR TO STENT DEPLOYMENT. IT IS NOT INDICATED IF THE USER HELD THE HANDLE OF THE SMART CONTROL SDS FLAT AND STRAIGHT OUTSIDE THE PATIENT. IPSILATERAL APPROACH WAS MADE FOR THE PROCEDURE. PRE-DILATION WAS CONDUCTED AT THE LESION AND THE SMART CONTROL WAS DELIVERED TO THE LESION BUT DURING DEPLOYMENT THE STENT JUMPED APPROXIMATELY 1CM DISTALLY SO THE PROXIMAL LESION OF THE COMMON ILIAC ARTERY WAS NOT COVERED. IT WAS NOT INDICATED IF UNUSUAL FORCE WAS APPLIED DURING DEPLOYMENT OF THE STENT. THE TARGET LESION WAS THE RIGHT COMMON ILIAC ARTERY. THE LESION BEGAN APPROXIMATELY 1CM BELOW FROM THE ILIAC BIFURCATION AND THE LESION WAS FROM THE RIGHT COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. IT IS UNKNOWN IF THE LESION WAS A DE NOVO BUT WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS WITH 85% STENOSIS. 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. REVIEW OF LOT 15667699 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. THE IFU STATES, "IF RESISTANCE IS MET DURING DELIVERY INTRODUCTION, THE SYSTEM SHOULD BE WITHDRAWN AND ANOTHER SYSTEM SHOULD BE USED." THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND WITH REVIEW OF THE DEVICE HISTORY RECORDS; THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE MANUFACTURING PROCESS. VESSEL CHARACTERISTICS AND PROCEDURAL HANDLING ADDRESSED IN THE IFU MAY HAVE CONTRIBUTED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY AN AFFILIATE, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), DEPLOYMENT DIFFICULTIES WAS EXPERIENCED WITH A SMART CONTROL SELF EXPANDING STENT (SES). THEREFORE, AN ADDITIONAL STENT WAS PLACED PROXIMALLY TO THE SMART CONTROL STENT AND THE ENTIRE LESION WAS FULLY COVERED. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION. THE LOCKING PIN WAS REMOVED BEFORE ATTEMPTING TO DEPLOY THE SMART CONTROL STENT. "THE SDS WAS ADVANCED PAST THE LESION AND THEN WITHDRAWN BACK INTO THE LESION PRIOR TO STENT DEPLOYMENT. IT IS NOT INDICATED IF THE USER HELD THE HANDLE OF THE SMART CONTROL SDS FLAT AND STRAIGHT OUTSIDE THE PATIENT. IPSILATERAL APPROACH WAS MADE FOR THE PROCEDURE. PRE-DILATION WAS CONDUCTED AT THE LESION AND THE SMART CONTROL (10.0/30MM) WAS DELIVERED TO THE LESION. THE STENT OF THE SMART CONTROL WAS RELEASED, BUT THE STENT JUMPED APPROXIMATELY 1CM DISTALLY DURING THE STENT DEPLOYMENT AND SO THE PROXIMAL LESION OF THE COMMON ILIAC ARTERY WAS NOT COVERED. IT WAS NOT INDICATED IF UNUSUAL FORCE WAS APPLIED DURING DEPLOYMENT OF THE STENT. THE TARGET LESION WAS THE RIGHT COMMON ILIAC ARTERY. THE LESION WAS BEGINNING FROM APPROXIMATELY 1CM BELOW FROM THE ILIAC BIFURCATION. THE TARGET LESION WAS FROM THE RIGHT COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. IT IS UNKNOWN IF THE LESION WAS A DE NOVO BUT WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS WITH 85% STENOSIS. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196892 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIO) NIO CORDIS DE MEXICO NA 15667699

    Patients

    Seq Age Sex Outcome Treatment
    1