BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1052345 · Received May 21, 2008

    Report

    Report Number
    9616099-2008-01361
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    March 21, 2008
    Report Date
    April 25, 2008
    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 PRODUCT IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    WITHDRAWAL DIFFICULTY. THE REPORT RECEIVED INDICATED THAT AFTER SUCCESSFULLY IMPLANTING, THE SMART CONTROL STENT, THE PHYSICIAN TRIED TO WITHDRAW THE STENT DELIVERY SYSTEM (SDS); HOWEVER, THE SDS COULD HARDLY BE WITHDRAWN AS IT WAS CAUGHT IN A STENT STRUT. THEREFORE, TO UNBEND THE HEAVILY TORTUOUS VESSEL, THE PHYSICIAN EXCHANGED THE GUIDE WIRE TO 0.035" STIFFER WIRE AND MANAGED TO REMOVE THE SDS SUCCESSFULLY. THERE WAS LARGE RESISTANCE WITHDRAWING; HOWEVER, THERE WERE NO ANOMALIES OBSERVED ON THE TIP OR IN THE DELIVERY SYSTEM. THE LESION WAS POST-DILATED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORT OF ADVERSE EVENT OR INJURY TO THE PATIENT. ADDITIONAL INFO INDICATED CONTRA LATERAL APPROACHED HAD BEEN CHOSEN FOR THE PROCEDURE. THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY INCLUDED TREATMENT OF A LESION IN THE EXTERNAL ILIAC ARTERY. THE TARGET LESION WAS HEAVY CALCIFIED WITH HEAVY VESSEL TORTUOUSITY AND PRESENTING 99% STENOSIS.

    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 13314009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PARENT MEDIKIT SHEATH| AMPLAZ SUPER STIFF WIRE