BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2140546 · Received June 27, 2011

    Report

    Report Number
    9616099-2011-00451
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    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 WAS PERFORMED AND THE FOLLOWING WAS FOUND: REVIEW OF LOT 15112456 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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. 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 THE IFU STATES, IF RESISTANCE IS MET DURING DELIVERY INTRODUCTION, THE SYSTEM SHOULD BE WITHDRAWN AND ANOTHER SYSTEM SHOULD BE USED.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, DEVICE INTERACTION AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    STENT PLACEMENT: THE TARGET LESION WAS LEFT SUPERFICIAL FEMORAL ARTERY. HEAVY CALCIFICATION AND MODERATE VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS 90%. CONTRALATERAL APPROACH. DIFFICULTY WAS EXPERIENCED WHILE ADVANCING SMART CONTROL (LOT# 15112456) THROUGH ARROW SHEATH INTRODUCER. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE DISTAL STENT WAS OBSERVED PREMATURELY DEPLOYED 1CM FROM THE SDS. SECOND SC (LOT# 15264660) WAS INSERTED IN THE SAME SHEATH INTRODUCER BUT THIS ONE ALSO COULD NOT GO THROUGH IT. LUMINEX STENT (MEDICON) WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER PROBLEM. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. NO PRODUCT RETURN. IT WAS REPORTED THAT THE ARROW SHEATH INTRODUCER HAD BEEN SLIGHTLY KINKED DURING THE PROCEDURE DUE TO THE HEAVY ANGLED BIFURCATION.

    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 15112456

    Patients

    Seq Age Sex Outcome Treatment
    1