BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 3980243 · Received August 5, 2014

    Report

    Report Number
    9616099-2014-00513
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    February 25, 2014
    Report Date
    July 10, 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

    AS REPORTED BY A QUAL REP, DECREASE IN THE ABI VALUE WAS OBSERVED AND ANGIOGRAM REVEALED IN STENT RESTENOSIS OF TWO SMART STENTS (6X150MM) AND (6X80MM) PLACED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. BALLOON DILATATION WAS CONDUCTED AND THE BLOOD FLOW WAS RESTORED. NO OTHER EVENTS OCCURRED. THE PATIENT IS DOING WELL NOW. THERE WAS 0% RESIDUAL STENOSIS AFTER THE INITIAL STENT IMPLANTATION. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. THE PATIENT WAS COMPLIANT ON ASPIRIN AND CLOPIDOGREL. (B)(4). THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT 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.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE IMPLANT DATE IS (B)(6) 2014. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG REPORT #9616099-2014-00511AND 9616099-2014-00513.

    Description of Event or Problem · 1

    AS REPORTED BY A QUAL REP, DECREASE IN THE ABI VALUE WAS OBSERVED AND ANGIOGRAM REVEALED IN STENT RESTENOSIS OF TWO SMART STENTS (6X150MM) AND (6X80MM) PLACED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. BALLOON DILATATION WAS CONDUCTED AND THE BLOOD FLOW WAS RESTORED. NO OTHER EVENTS OCCURRED. THE PATIENT IS DOING WELL NOW. THERE WAS 0% RESIDUAL STENOSIS AFTER THE INITIAL STENT IMPLANTATION. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. THE PATIENT WAS COMPLAINT ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457371 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIO) NIO CORDIS DE MEXICO NA 15646994

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R ASPIRIN AND CLOPIDOGREAL