BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 4067292 · Received September 8, 2014

    Report

    Report Number
    9616099-2014-00573
    Event Type
    Injury
    Date Received
    September 8, 2014
    Date of Event
    May 13, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: APPROXIMATELY ELEVEN MONTHS POST STENTING PROCEDURE TO THE SUPERFICIAL FEMORAL ARTERY (SFA), IT WAS REPORTED THAT BY ANGIOGRAPHY, RESTENOSIS WAS FOUND IN THE TWO SMART CONTROL STENTS PREVIOUSLY IMPLANTED. THE PATIENT SUFFERED INTERMITTENT CLAUDICATION (ONSET IS UNKNOWN). THE PATIENT RECEIVED MEDICATION. THE TWO SMART CONTROL STENTS WERE ORIGINALLY PLACED IN THE TARGET LESION WITHOUT ANY ISSUE. AT THAT TIME, THE LESION WAS MILDLY CALCIFIED AND TORTUOUS. THE RATE OF STENOSIS WAS 100%. 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 LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. 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. STENOSIS IN STENTS IS USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. FACTORS THAT MAY HAVE INFLUENCED THIS EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2014-00574.

    Description of Event or Problem · 1

    APPROXIMATELY ELEVEN MONTHS POST STENTING PROCEDURE TO THE SUPERFICIAL FEMORAL ARTERY (SFA), IT WAS REPORTED THAT BY ANGIOGRAPHY, RESTENOSIS WAS FOUND IN THE TWO SMART CONTROL STENTS PREVIOUSLY IMPLANTED. THE PATIENT SUFFERED INTERMITTENT CLAUDICATION (ONSET IS UNKNOWN). THE PATIENT RECEIVED MEDICATION. THE TWO SMART CONTROL STENTS WERE ORIGINALLY PLACED IN THE TARGET LESION WITHOUT ANY ISSUE. AT THAT TIME, THE LESION WAS MILDLY CALCIFIED AND TORTUOUS. THE RATE OF STENOSIS WAS 100%. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550145 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIO) NIO CORDIS DE MEXICO NA 15580653

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention