BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2230468 · Received September 1, 2011

    Report

    Report Number
    9616099-2011-00701
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 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 PATIENT WAS ADMITTED WITH A 90%, MODERATELY CALCIFIED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. IT WAS REPORTED THAT THE BIFURCATION WAS HEAVILY ANGLED AND THE VESSEL WAS HEAVILY TORTUOUS AND THAT IT WAS VERY DIFFICULT TO ADVANCE THE SMART CONTROL STENT TO THE TARGET LESION. WHILE MOVING THE STENT DELIVERY SYSTEM BACK AND FORTH, APPROXIMATELY 1MM OF THE DISTAL STENT BECAME PREMATURELY DEPLOYED. THE STENT DELIVERY SYSTEM WAS SAFELY REMOVED FROM THE PATIENT. ANOTHER PRODUCT WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER PROBLEM. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE, THERE WERE NO ANOMALIES NOTED ON THE OUTER BOX, INNER POUCH OR ON THE ACTUAL PRODUCT PRIOR TO USE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND: REVIEW OF LOT 15355016 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, AS IN THIS PROCEDURE, CAN CAUSE THE OUTER MEMBER TO COMPRESS, THUS CONTRIBUTING TO PREMATURE STENT DEPLOYMENT/STENT JUMPING WITH THE LOCKING PIN STILL IN. 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. 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 PATIENT WAS ADMITTED WITH A 90%, MODERATELY CALCIFIED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. IT WAS VERY DIFFICULT TO ADVANCE SMART CONTROL STENT TO THE TARGET LESION. IT WAS REPORTED THAT THE BIFURCATION WAS HEAVILY ANGLED AND THE VESSEL WAS ALSO HEAVILY TORTUOUS. WHILE MOVING THE STENT DELIVERY SYSTEM BACK AND FORTH, APPROXIMATELY 1MM OF THE DISTAL STENT BECAME PREMATURELY DEPLOYED. THE STENT DELIVERY SYSTEM WAS SAFELY REMOVED FROM THE PATIENT. ANOTHER PRODUCT WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER PROBLEM. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION.

    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 15355016

    Patients

    Seq Age Sex Outcome Treatment
    1