BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1190287 · Received October 6, 2008

    Report

    Report Number
    9616099-2008-02394
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS REPORTED TO BE: MILDLY CALCIFIED, A 100% OCCLUSION, A CHRONIC TOTAL OCCLUSION (CTO), AND NOT TORTUOUS. ACCESS FOR THE PROCEDURE WAS MADE FROM THE IPSILATERAL APPROACH (BEHIND THE KNEE) AND CONTRALATERAL VIA FEMORAL APPROACH. THE LESION WAS PRE-DILATED. TWO 6 X 100 SMART CONTROL STENTS WERE SUCCESSFULLY DEPLOYED PRIOR TO THE AFOREMENTIONED PRODUCT PROBLEM. THE PRODUCTS WERE ALL INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. NO UNUSUAL FORCE WAS USED DURING THE PROCEDURE AND THE PRODUCT WAS PREPPED AND DEPLOYED PROPERLY ACCORDING TO THE IFU. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT AFTER DEPLOYING A THIRD SMART CONTROL 6X100 STENT, THE STENT APPEARED TO BE 8CM LONG INSTEAD OF 10 CM AND THE STENT STRUTS APPEARED TO BE FOLDED/OVERLAPPING EACH OTHER. AN ADDITIONAL (FOURTH) STENT WAS IMPLANTED AND WAS POST-DILATED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PT INJURY.

    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 13293278

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention SHEATH: TERUMO 6F 25CM| GW: TREASURE (ST. JUDE),| BC (SUBMARINE (ST. JUDE)