BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2922410 · Received January 18, 2013

    Report

    Report Number
    9616099-2013-00025
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 15428621 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA)/STENTING PROCEDURE, AFTER DELIVERING THE SMART CONTROL STENT TO THE TARGET LESION THE PHYSICIAN EXPERIENCED DIFFICULTY ROTATING THE TUNING DIAL TO DEPLOY THE STENT. WITH GREAT EFFORT THE DIAL COULD BE ROTATED AND THE STENT WAS DEPLOYED. HOWEVER, THE STENT MISSED THE TARGET LESION AND DID NOT FULLY COVER THE LESION REQUIRING PLACEMENT OF AN ADDITIONAL STENT TO FULLY COVER THE LESION. A CONTRALATERAL APPROACH WAS CHOSEN FOR THIS PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED, AND THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS DUE TO THE PATIENT'S INFECTIOUS DISEASE. THE TARGET LESION WAS A 99% STENOSED, HEAVILY CALCIFIED AND MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 15428621 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". IT IS POSSIBLE THAT THE OPERATOR'S INTERACTION WITH THE SDS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. HOLDING THE OUTER MEMBER DURING DEPLOYMENT MAY RESULT IN THE SUPPORT MEMBER PUSHING THE STENT FORWARD AND COMPRESSING THE STENT. IN ADDITION, MOVING THE HANDLE PROXIMALLY OR DISTALLY AFTER THE STENT ACHIEVES INITIAL WALL APPOSITION MAY RESULT IN STENT COMPRESSION OR ELONGATION. 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 ADDRESSED IN THE IFU MAY HAVE CONTRIBUTED TO THE EVENT 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

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA)/STENTING PROCEDURE, AFTER DELIVERING THE SMART CONTROL 7 X 100 CM. STENT/COMPLAINT PRODUCT TO THE TARGET LESION, THE PHYSICIAN EXPERIENCED DIFFICULTY ROTATING THE TUNING DIAL TO DEPLOY THE STENT. WITH THE GREAT EFFORT, THE DIAL COULD BE ROTATED AND THE STENT WAS DEPLOYED. HOWEVER, THE STENT MISSED THE TARGET LESION AND COULD NOT FULLY COVER THE LESION. AN ADDITIONAL STENT WAS PLACED AND THE LESION WAS FULLY COVERED. THE PROCEDURE WAS FINISHED SUCCESSFULLY. A CONTRALATERAL APPROACH WAS CHOSEN FOR THIS PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED, AND THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS DUE TO THE PATIENT'S INFECTIOUS DISEASE. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THE LESION WAS REPORTED TO BE: A 99% STENOSIS, HEAVILY CALCIFIED AND MILDLY TORTUOUS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27864 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIO) NIO CORDIS DE MEXICO NA 15627236

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BOSTON SCIENTIFIC AGURU GUIDEWIRE