BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1896861 · Received November 11, 2010

    Report

    Report Number
    9616099-2010-00860
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 13, 2010
    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 PATIENT WAS A (B)(6) FEMALE. THE TARGET LESION WAS LOCATED IN THE BIFURCATION OF THE SUPERFICIAL FEMORAL ARTERY. THERE WAS MODERATE CALCIFICATION AND VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS 100%. APPROACH WAS MADE FROM BEHIND THE KNEE. A SMART CONTROL WAS UNABLE TO CROSS THE TARGET LESION. THE DEVICE WAS REMOVED AND THE DISTAL TIP WAS NOTED FRAYED. ANOTHER NEW PRODUCT WAS OPENED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER ISSUES. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND: REVIEW OF LOT 15034800 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. 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 EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT WAS A (B)(6) FEMALE. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (BIFURCATION). THERE WAS MODERATE CALCIFICATION AND VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS 100%. APPROACH WAS MADE FROM BEHIND THE KNEE. A SMART CONTROL (COMPLAINT PRODUCT) WAS UNABLE TO CROSS THE TARGET LESION. THE DEVICE WAS ONCE REMOVED BUT THE DISTAL TIP WAS OBSERVED FRAYED. ANOTHER NEW PRODUCT (DETAILS UNK) WAS OPENED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER ISSUES. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. NO PRODUCT RETURN.

    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 15034800

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR