BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 4071456 · Received September 9, 2014

    Report

    Report Number
    9616099-2014-00577
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    February 28, 2014
    Report Date
    August 13, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT #9616099-2014-00578.

    Additional Manufacturer Narrative · 1

    FOUR MONTHS POST STENTING PROCEDURE WITH TWO SMART CONTROL STENTS TO THE SUPERFICIAL FEMORAL ARTERY (SFA), IT WAS REPORTED THAT RESTENOSIS WAS FOUND IN THE PLACED STENTS. THE LESION WAS TREATED BY PTA (POBA). THE PATIENT RECOVERED. AT THE TIME OF STENT IMPLANTATIONS, THE LESION WAS HEAVILY CALCIFIED AND THE RATE OF STENOSIS WAS 50-99%. THE PATIENT¿S ADMITTING MEDICATIONS ARE UNKNOWN. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. THE PATIENT WAS COMPLIANT WITH ANTIPLATELET THERAPY. THIS IS A CASE FROM (B)(4) SMART PMS FOR SFA. (B)(4). THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LO IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURAL AND IT LISTED IN THE IFU. IN THE LITERATURE, IN-STENT STENOSIS RATES FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER THE STENT PLACEMENT. RATES ARE HIGHER IN OLDER PATIENT WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. STENOSIS IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT THEREFORE; NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, SPECIFICALLY THE RISK FACTORS FOR ATHEROSCLEROTIC DISEASE.

    Description of Event or Problem · 1

    FOUR MONTHS POST STENTING PROCEDURE WITH TWO SMART CONTROL STENTS TO THE SUPERFICIAL FEMORAL ARTERY (SFA), IT WAS REPORTED THAT RESTENOSIS WAS FOUND IN THE PLACED STENTS. THE LESION WAS TREATED BY PTA (POBA). THE PATIENT RECOVERED. AT THE TIME OF STENT IMPLANTATIONS, THE LESION WAS HEAVILY CALCIFIED AND THE RATE OF STENOSIS WAS (B)(4). THE PATIENT¿S ADMITTING MEDICATIONS ARE UNKNOWN. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. THE PATIENT WAS COMPLIANT WITH ANTIPLATELET THERAPY. THIS IS A CASE FROM (B)(6) SMART PMS FOR SFA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554739 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIO) NIO CORDIS DE MEXICO NA 15558029

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention