BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 4095197 · Received September 17, 2014

    Report

    Report Number
    9616099-2014-00596
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    March 4, 2014
    Report Date
    August 28, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: APPROXIMATELY NINE MONTHS POST PROCEDURE INVOLVING THE STENTING OF THE SUPERFICIAL FEMORAL ARTERY WITH A SMART CONTROL STENT, IT WAS REPORTED THAT RESTENOSIS WAS FOUND IN THE PLACED STENT. TWENTY-ONE DAYS LATER THE LESION WAS TREATED BY PTA (POBA). THE PATIENT RECOVERED WELL. AT THE TIME OF THE SMART CONTROL PLACEMENT, THE LESION WAS MODERATELY CALCIFIED AND NOT TORTUOUS. THE RATE OF STENOSIS WAS 75%. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. THE PATIENT WAS COMPLIANT ON THE POST PROCEDURE REGIME OF ANTIPLATELET THERAPY (ASPIRIN AND CLOPIDOGREL). THIS IS A CASE FROM JAPAN SMART PMS FOR SFA AND THE CASE NUMBER IS (B)(4). THE PRODUCT REMAINS IMPLANTED. NCD WILL NOT PERFORM A FORMER DHR REVIEW FOR A COMPLAINT THAT DIES NOT IDENTIFY A DEVICE RELATED DEFECT. IN-STENT RESTENOSIS (ISR) IS ASSOCIATED WITH THE PROGRESSION OF ATHEROSCLEROTIC DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND DOES NOT REPRESENT A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS, IT IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. VESSEL OCCLUSION, RESTENOSIS, INTIMAL HYPERPLASIA OR RECURRENT STRICTURES ARE WELL KNOWN DOCUMENTED POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. RATES ARE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. ISR IS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. FACTORS THAT MAY HAVE INFLUENCED THIS EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    APPROXIMATELY NINE MONTHS POST PROCEDURE INVOLVING THE STENTING OF THE SUPERFICIAL FEMORAL ARTERY WITH A SMART CONTROL STENT, IT WAS REPORTED THAT RESTENOSIS WAS FOUND IN THE PLACED STENT. TWENTY-ONE DAYS LATER THE LESION WAS TREATED BY PTA (POBA). THE PATIENT RECOVERED WELL. AT THE TIME OF THE SMART CONTROL PLACEMENT, THE LESION WAS MODERATELY CALCIFIED AND NOT TORTUOUS. THE RATE OF STENOSIS WAS 75%. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. THE PATIENT WAS COMPLIANT ON THE POST PROCEDURE REGIME OF ANTIPLATELET THERAPY (ASPIRIN AND CLOPIDOGREL). THIS IS A CASE FROM (B)(6) SMART PMS FOR SFA AND THE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575166 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIO) NIO CORDIS DE MEXICO NA 15766824

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R