BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2901592 · Received January 8, 2013

    Report

    Report Number
    9616099-2013-00016
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    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

    COMPLAINT CONCLUSION: IT WAS NOTED THAT FRICTION/RESISTANCE WAS ENCOUNTERED WHILE TRACKING THE SMART CONTROL STENT DELIVERY SYSTEM (SDS) TOWARDS THE 100% STENOSED (CTO) SUPERFICIAL FEMORAL ARTERY. PRE-DILATION WAS CONDUCTED WITH AN UNKNOWN 3 MM BALLOON CATHETER BUT WHEN THE SDS WAS ADVANCED INTO THE ARTERY RESISTANCE WAS FELT. IT IS UNKNOWN IF THE TARGET LESION WAS DE NOVO, CALCIFIED OR TORTUOUS. THE PHYSICIAN PUSHED THE SDS TO ADVANCE IT FORWARD, HOWEVER, IT WAS OBSERVED THAT THE DISTAL PORTION OF THE STENT HAD SLIGHTLY RELEASED AND THE PHYSICIAN DECIDED TO DEPLOY THE STENT PROXIMALLY TO THE INTENDED POSITION. IT WAS NOT INDICATED IF EXCESSIVE FORCE WAS USED DURING THE PROCEDURE. AN UNKNOWN ADDITIONAL STENT WAS DEPLOYED AND IMPLANTED IN THE DISTAL PORTION OF THE LESION. THERE WAS NO PATIENT INJURY REPORTED. 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 15621159 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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 THE IFU STATES, "IF RESISTANCE IS MET DURING DELIVERY INTRODUCTION, THE SYSTEM SHOULD BE WITHDRAWN AND ANOTHER SYSTEM SHOULD BE USED".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 REPORTED EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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.

    Description of Event or Problem · 1

    AS REPORTED BY AN AFFILIATE, DURING A PTA (STENTING) PROCEDURE, PRE-DILATION WAS CONDUCTED WITH AN UNKNOWN 3 MM BALLOON CATHETER. THE LESION WAS CROSSED WITH AN UNKNOWN GUIDEWIRE AND A 6.0 X 40 MM SMART CONTROL WAS ADVANCED INTO THE ARTERY, BUT THERE WAS FRICTION/RESISTANCE WHILE TRACKING THE SDS TOWARD THE LESION. THE TARGETED LESION WAS THE SUPERFICIAL FEMORAL ARTERY WHICH HAD 100% STENOSIS (CTO). IT IS UNKNOWN IF THE TARGET LESION WAS DE NOVO, CALCIFIED OR TORTUOUS. THE PHYSICIAN PUSHED THE SMART CONTROL TO ADVANCE IT FORWARD, HOWEVER, IT WAS CONFIRMED THAT DISTAL PORTION OF THE STENT WAS SLIGHTLY RELEASED UNDER THE X-RAY. THE SMART CONTROL WAS NOT DELIVERED TO THE INTENDED POSITION FOR ITS STENT PLACEMENT, BUT IT WAS IMPLANTED PROXIMALLY TO THE INTENDED POSITION. IT WAS NOT INDICATED IF EXCESSIVE FORCE WAS USED DURING THE PROCEDURE. AN UNKNOWN ADDITIONAL STENT WAS DEPLOYED AND IMPLANTED IN THE DISTAL PORTION OF THE LESION. THE PROCEDURE WAS FINISHED SUCCESSFULLY, THE POST PROCEDURE STENOSIS IS UNKNOWN . THERE WAS NO PATIENT INJURY REPORTED AND THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. A SECOND STENT WAS REQUIRED TO COVER THE LESION SINCE THE SMART CONTROL WAS PREMATURELY DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9128 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIO) NIO CORDIS DE MEXICO NA 15621159

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening