BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1140564 · Received August 28, 2008

    Report

    Report Number
    9616099-2008-02104
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 4, 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

    ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED FOR A PROCEDURE IN 2008, WITH A 95% HEAVILY CALCIFIED LESION IN THE EXTERNAL ILIAC ARTERY. IT WAS NOTED THAT THE VESSEL WAS TORTUOUS. AFTER THE GUIDEWIRE (BRAND UNKNOWN) CROSSED THE LESION, IT WAS PRE-DILATED AND A SMART CONTROL NITINOL STENT WAS DELIVERED. DURING DELIVERY, FRICTION OCCURRED BETWEEN THE SMART CONTROL AND THE GUIDEWIRE, INSIDE OF THE SHEATH. AS THEY COULD NOT MOVE AT ALL, BOTH DEVICES WERE PULLED OUT. AFTER REMOVAL FROM THE PATIENT, THE STENT WAS NOTED PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SIZE PROCEDURE AND WITH A STIFFER GUIDEWIRE. THE PHYSICIAN DECEIVED TO CHANGE THE WIRE AS IT COULD STRAIGHTEN THE TORTUOUS VESSEL AND MAKE IT EASIER TO TRACK TO THE LESION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

    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 13371105

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK THE FOLLOWING PRODUCTS WERE USED DURING THE| 6F MEDIKIT PARENT SHEATH| PROCEDURE: AN AMPLATZ GUIDEWIRE