BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2800195 · Received October 22, 2012

    Report

    Report Number
    9616099-2012-00605
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 15, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE STATES THAT WHEN THE SMART STENT WAS DEPLOYED IT JUMPED FORWARD AND WAS DEPLOYED DISTAL TO THE LESION. THE TARGET LESION WAS A HEAVILY CALCIFIED AND MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. IT IS UNKNOWN IF THE LESION WAS A DE NOVO AS WELL AS THE % OF STENOSIS. CONTRALATERAL APPROACH WAS CHOSEN FOR THE PROCEDURE. AFTER BEING PROPERLY INSPECTED AND PREPPED A 7.0/40MM 120CM SMART CONTROL WAS DELIVERED TO THE TARGET LESION AND THE STENT WAS CAREFULLY RELEASED, HOWEVER, THE STENT JUMPED AND WAS DEPLOYED DISTAL TO THE LESION. IT IS UNKNOWN IF THERE WAS ANY DIFFICULTY OR RESISTANCE NOTED WHILE CROSSING THE LESION OR IF THE LESION WAS PRE-DILATED. THE PROXIMAL PORTION OF THE LESION WAS NOT COVERED SO AN ADDITIONAL STENT WAS PLACED WHICH FULLY COVERED THE LESION AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. ONE NON-STERILE SMART CONTROL, ILIAC 7X40ML WAS RECEIVED COILED INSIDE A PLASTIC BAG. UNIT WAS DEPLOYED. STENT WAS NOT RECEIVED. A KINK WAS OBSERVED AT 7.5CM FROM ID BAND. NO OTHER DISCREPANCIES WERE FOUND. THE OUTER LENGTH WAS MEASURED AND FOUND WITHIN SPECIFICATION. ALTHOUGH THE STENT WAS NOT RECEIVED; FUNCTIONAL TEST (DEPLOYMENT PROCESS) WAS PERFORMED AND NO ANOMALIES WERE 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 EXACT CAUSE OF KINK CONDITION COULD NOT BE CONCLUSIVELY DETERMINED. DURING MANUFACTURING PROCESS THERE ARE CONTROLS TO DETECT THIS KIND OF DAMAGE. THE FAILURE REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED SINCE NO ANOMALIES WERE FOUND DURING DIMENSIONAL AND FUNCTIONAL ANALYSES. THE CAUSE OF THE FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. THE FAILURE DOES NOT APPEAR TO BE MANUFACTURING RELATED. NEITHER THE DHR REVIEW NOR THE ANALYSIS SUGGESTS THAT THE FAILURE IS MANUFACTURING PROCESS. THEREFORE NO ACTIONS WERE TAKEN. 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.' BASED ON THE INFORMATION PROVIDED VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE STATES THAT WHEN THE SMART STENT WAS DEPLOYED IT JUMPED FORWARD AND WAS DEPLOYED AT THE DISTAL LESION. THE PATIENT'S AGE AND GENDER WERE UNKNOWN. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY. IT IS UNKNOWN IF THE LESION WAS A DE NOVO, BUT WAS HEAVILY CALCIFIED AND MODERATELY TORTUOUS. THE % OF THE STENOSIS WAS UNKNOWN. CONTRALATERAL APPROACH WAS CHOSEN FOR THE PROCEDURE. AFTER BEING PROPERLY INSPECTED AND PREPPED A SMART CONTROL (7.0/40MM 120CM: COMPLAINT PRODUCT) WAS DELIVERED TO THE TARGET LESION AND THE STENT WAS CAREFULLY RELEASED, BUT THE STENT JUMPED AND WAS DEPLOYED AT THE DISTAL LESION. IT IS UNKNOWN IF THERE WAS ANY DIFFICULTY OR RESISTANCE NOTED WHILE CROSSING THE LESION WITH THE STENT. IT IS UNKNOWN IF THE LESION WAS PRE-DILATED. THE PROXIMAL PORTION OF THE LESION COULD NOT BE COVERED SO AN ADDITIONAL STENT (UNSPECIFIED: 60MM) WAS PLACED PROXIMALLY TO THE SMART CONTROL STENT. THE TARGET LESION WAS FULLY COVERED AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED.

    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 15624207

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R