BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2000375 · Received February 24, 2011

    Report

    Report Number
    9616099-2011-00127
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS ADMITTED WITH A TOTALLY OCCLUDED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS MODERATELY CALCIFIED AND THE VESSEL WAS MODERATELY TORTUOUS. A SMART CONTROL STENT DELIVERY SYSTEM WAS DELIVERED; HOWEVER, THE STENT JUMPED FORWARD DURING STENT DEPLOYMENT AND DID NOT FULLY COVER THE LESION. THEREFORE, AN ADDITIONAL STENT WAS PLACED AND THE WHOLE LESION WAS FULLY COVERED. THERE WAS NO PATIENT INJURY REPORTED. ACCORDING TO THE INFORMATION THE DEVICE WAS PREPPED AND USED PER THE IFU. THERE WAS NO DIFFICULTY ENCOUNTERED WHILE ADVANCING/TRACKING THE SDS TOWARDS THE LESION AND NO UNUSUAL FORCE WAS USED AT ANY TIME DURING THE PROCEDURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND: REVIEW OF LOT 15153159 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). WITH THE 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 TOTALLY OCCLUDED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS MODERATELY CALCIFIED AND THE VESSEL WAS MODERATELY TORTUOUS. A SMART CONTROL WAS DELIVERED, HOWEVER, THE STENT JUMPED FORWARD DURING STENT DEPLOYMENT AND COULD NOT COVER THE LESION. THEREFORE, AN ADDITIONAL STENT WAS PLACED AND THE WHOLE LESION WAS FULLY COVERED. 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 15153159

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention