BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2090372 · Received May 16, 2011

    Report

    Report Number
    9616099-2011-00335
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 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 THE FOLLOWING WAS FOUND: REVIEW OF LOT 15300388 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 ATTEMPT TO CROSS THE LESION. AN INTERNAL CORDIS INVESTIGATION REVEALED THAT PUSHING THE SDS AGAINST RESISTANCE CAN CAUSE THE OUTER MEMBER TO COMPRESS, THUS CONTRIBUTING TO PREMATURE STENT DEPLOYMENT/STENT JUMPING WITH THE LOCKING PIN 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 THE IFU STATES, "IF RESISTANCE IS MET DURING DELIVERY INTRODUCTION, THE SYSTEM SHOULD BE WITHDRAWN AND ANOTHER SYSTEM SHOULD BE USED."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

    WHILE ATTEMPTING TO DEPLOY A STENT IN THE COMMON ILIAC ARTERY IT WAS REPORTED THAT THE STENT JUMPED FORWARD REQUIRING PLACEMENT OF AN ADDITIONAL STENT PROXIMAL TO THE FIRST. THE LESION WAS DESCRIBED AS HAVING MILD CALCIFICATION AND VESSEL TORTUOSITY WITH AN 80% STENOSIS. IT WAS NOTED THAT THE SMART CONTROL DID PASS THROUGH ACUTE BENDS, AND IT WAS NOT KNOWN IF HIGH FORCE WAS USED DURING DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

    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 15300388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention