BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1202193 · Received October 16, 2008

    Report

    Report Number
    9616099-2008-02467
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 18, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVAL AND TESTING; HOWEVER, AS OF TO DATE, THE EVAL HAS NOT BEEN COMPLETED. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT THE SMART CONTROL SYSTEM SEPARATED IN THREE PLACES WHILE ON THE WIRE. FURTHER INFO INDICATED THAT THE PROBLEM OCCURRED AFTER THE STENT HAD BEEN DEPLOYED, THERE WERE NO PROBLEMS DURING OR WITH THE STENT PLACEMENT; HOWEVER, THE PROBLEM OCCURRED DURING REMOVAL OF THE DELIVERY SYSTEM. ACCORDING TO THE REPORTER, THE WIRE USED WAS A HYDROPHILIC WIRE AND WHEN THE WIRE IS NOT PROPERLY LUBRICATED, THE COATING BECOMES A GEL; AS SUCH, THE WIRE GOT STUCK TO THE WIRE LUMEN OF THE STENT DELIVERY SYSTEM (SDS). WHILE REMOVING THE SDS FROM THE PT, THE PHYSICIAN ENCOUNTERED RESISTANCE, THE PHYSICIAN CONTINUED TO PULL WITH SOME FORCE; AT THAT TIME THE PHYSICIAN IDENTIFIED THE DEVICE SEPARATION. FORTUNATELY, ALL THE CATHETER PIECES REMAINED ON THE WIRE, THE PHYSICIAN REMOVED BOTH, THE DELIVERY SYSTEM AND THE WIRE, AS A SINGLE UNIT; AS SUCH, THE ENTIRE DEVICE WAS REMOVED FROM THE PT WITHOUT COMPLICATIONS; THERE WAS NO REPORT OF INJURY TO THE PT.

    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 13277965

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BOSTON SCIENTIFIC ZIP WIRE