BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 4100935 · Received September 19, 2014

    Report

    Report Number
    9616099-2014-00602
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    July 8, 2014
    Report Date
    August 27, 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 REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED EVENT AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 9616099-2014-00601 AND 9616099-2014-00602.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY (B)(4) STUDY, RESTENOSIS WAS FOUND IN TWO SMART CONTROL STENTS (6X80 AND 7X40 ILIAC STENTS) APPROXIMATELY ONE YEAR AFTER THEY WERE PLACED IN THE SUPERFICIAL FEMORAL ARTERY. THE LESION WAS TREATED WITH PTA AND THE PATIENT RECOVERED. THE INITIAL RATE OF STENOSIS WAS 75%. TWO SMART CONTROL STENTS WERE PLACED IN THE TARGET LESION WITHOUT ANY ISSUE. THE SYMPTOMS PRESENT DURING THE INITIAL PROCEDURE ARE UNKNOWN. THE TARGET LESION WAS DE NOVO, CALCIFIED, NOT OSTIAL AND WITH NO VESSEL TORTUOSITY PRESENT. IT IS NOT KNOWN IF IT WAS DIFFICULT TO ACCESS OR WIRE THE LESION. THE SITE WAS PREDILATED PRIOR TO STENT IMPLANTATION BUT THE BALLOON SIZE AND INFLATION PRESSURE IS NOT KNOWN. IT IS NOT KNOWN IF POST DILATATION WAS PERFORMED. IT WAS NOT REPORTED IF THE PATIENT HAD ANY SYMPTOMS PRIOR TO FINDING THE RESTENOSIS. IT IS UNKNOWN IF ANY DOPPLER TESTING OR ANGIOGRAPHY WAS PERFORMED. THE PERCENTAGE OF RESTENOSIS IS NOT KNOWN. 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. THERE IS NO INFORMATION TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED EVENT AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 9616099-2014-00601 AND 9616099-2014-00602.

    Description of Event or Problem · 1

    AS REPORTED BY (B)(6), RESTENOSIS WAS FOUND IN TWO SMART CONTROL STENTS (6X80 AND 7X40 ILIAC STENTS) APPROXIMATELY ONE YEAR AFTER THEY WERE PLACED IN THE SUPERFICIAL FEMORAL ARTERY. THE LESION WAS TREATED WITH PTA AND THE PATIENT RECOVERED. THE INITIAL RATE OF STENOSIS WAS 75%. TWO SMART CONTROL STENTS WERE PLACED IN THE TARGET LESION WITHOUT ANY ISSUE. THE SYMPTOMS PRESENT DURING THE INITIAL PROCEDURE ARE UNKNOWN. THE TARGET LESION WAS DE NOVO, CALCIFIED, NOT OSTIAL AND WITH NO VESSEL TORTUOSITY PRESENT. IT IS NOT KNOWN IF IT WAS DIFFICULT TO ACCESS OR WIRE THE LESION. THE SITE WAS PREDILATED PRIOR TO STENT IMPLANTATION BUT THE BALLOON SIZE AND INFLATION PRESSURE IS NOT KNOWN. IT IS NOT KNOWN IF POST DILATATION WAS PERFORMED. IT WAS NOT REPORTED IF THE PATIENT HAD ANY SYMPTOMS PRIOR TO FINDING THE RESTENOSIS. IT IS UNKNOWN IF ANY DOPPLER TESTING OR ANGIOGRAPHY WAS PERFORMED. THE PERCENTAGE OF RESTENOSIS IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584246 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIO) NIO CORDIS DE MEXICO NA 15648516

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R