BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 2854625 · Received December 3, 2012

    Report

    Report Number
    9616099-2012-00715
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE STATES THAT WHEN A SMART CONTROL SDS WAS ABOUT TO BE INSERTED INTO A SHEATH INTRODUCER, THE STENT WAS OBSERVED TO BE PREMATURELY DEPLOYED BY APPROXIMATELY 3MM. NEVERTHELESS, THE PHYSICIAN TRIED TO ADVANCE THE SMART CONTROL SDS INTO THE PATIENT, BUT IT WOULD NOT ADVANCE FURTHER THE ILIAC BIFURCATION. THEREFORE, THE PHYSICIAN RETRIEVED THE SDS FROM THE PATIENT. A DIFFERENT SMART CONTROL WAS USED AND PLACED AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. THE PRODUCTS WERE PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. CONCOMITANT DEVICES: GW: B BRAUN'S, GW: ASAHI INTECC'S, BC: SLALOMTHRILL 6X40MM, SHEATH: MEDIKIT'S, STENT: SMARTCONTROL 8X60MM.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE STATES THAT WHEN A SMART CONTROL (10/60MM 80CM) WAS ABOUT TO BE INSERTED INTO A SHEATH INTRODUCER, THE STENT WAS OBSERVED TO BE PREMATURELY DEPLOYED (APPROXIMATELY 3MM). THE PATIENT WAS AN (B)(6) MALE. THE TARGET LESION WAS THE RIGHT EXTERNAL ILIAC ARTERY AND COMMON ILIAC ARTERY. THE LESION WAS A DE NOVO, SLIGHTLY CALCIFIED, AND MODERATELY TORTUOUS. THERE WAS 90% STENOSIS. THE PRODUCTS WERE PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. INITIALLY, TREATMENT FOR THE RIGHT EXTERNAL ILIAC ARTERY WAS CONDUCTED BY CONTRALATERAL APPROACH. BALLOONING WAS CONDUCTED, AND A STENT (SMART CONTROL 8/60MM) WAS PLACED AT THE RIGHT EXTERNAL ILIAC ARTERY. AFTERWARDS, TREATMENT FOR THE RIGHT COMMON ILIAC ARTERY WAS CONDUCTED. WHEN SMART CONTROL (10/60MM 80CM) WAS ABOUT TO BE INSERTED INTO A SHEATH INTRODUCER, THE STENT WAS OBSERVED TO BE RELEASED (APPROXIMATELY 3MM). NEVERTHELESS, THE PHYSICIAN TRIED TO ADVANCE THE SMART CONTROL INTO THE PATIENT, BUT IT WOULD NOT ADVANCE FURTHER THE ILIAC BIFURCATION. THEREFORE, THE PHYSICIAN STOPPED USING THE SMART CONTROL WITHOUT STENT PLACEMENT. THE PRODUCT WAS RETRIEVED FROM THE PATIENT IN THE CONDITION OF STENT PROTRUDING. A DIFFERENT SMART CONTROL (10/60MM) WAS USED AND PLACED INSTEAD. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT'S INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIO) NIO CORDIS DE MEXICO NA 15619450

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR