BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1061012 · Received June 12, 2008

    Report

    Report Number
    9616099-2008-01503
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    March 25, 2008
    Report Date
    May 19, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MFG QUALITY PLAN. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AFTER ENCOUNTERING RESISTANCE DURING ADVANCEMENT, THE STENT WAS FOUND PARTIALLY DEPLOYED. THE REPORT RECEIVED INDICATED THAT DURING A STENTING PROCEDURE TO THE EXTERNAL ILIAC ARTERY, THE SMART CONTROL WAS DELIVERED; HOWEVER, SOME RESISTANCE WAS ENCOUNTERED, THE DEVICE GOT STUCK INSIDE THE SHEATH AND DID NOT MOVE. THEREFORE, THE PHYSICIAN WITHDREW THE SMART CONTROL AND FOUND THE STENT WAS PARTIALLY DEPLOYED. CONSEQUENTLY, TO STRAIGHTEN THE TORTUOUS VESSEL AND DELIVER THE DEVICE EASIER, THE PHYSICIAN CHANGED THE WIRE FOR A STIFFER TYPE. THEN ANOTHER DELIVERY SYSTEM WAS ADVANCED AND THE STENT WAS PLACED SUCCESSFULLY. POST-DILATATION WAS FOLLOWED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE EVENT OR INJURY REPORTED. FURTHER INFORMATION INDICATED THE LESION WAS HEAVILY CALCIFIED AND HEAVILY TORTUOUS PRESENTING A 95% STENOSIS RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS NIO CORDIS DE MEXICO NA 13086155

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MEDIKIT PARENT SHEATH| AMPLAZ SUPERSTIFF WIRE 0.035| GUIDE WIRE