BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1111899 · Received August 12, 2008

    Report

    Report Number
    9616099-2008-01970
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 16, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K042969
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVAL AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING DEPLOYMENT OF A SMART CONTROL STENT IN THE LEFT SUPERFICIAL FEMORAL ARTERY, THE STENT WAS REPORTED TO HAVE BOUND UP AND DEPLOYED AT ONLY HALF OF ITS TRUE LENGTH. A COVERED STENT WAS DEPLOYED INSIDE THE SMART CONTROL STENT TO COVER THE LESION. THERE WAS NO REPORT OF PT INJURY. THE LESION WAS NEITHER CALCIFIED NOR TORTUOUS, AND WAS PRE-DILATED PRIOR TO STENTING. THERE WAS NO REPORTED DIFFICULTY ADVANCING THE SDS TO THE LESION OR CROSSING THE LESION, WHICH WAS NOTED TO BE 130MM IN LENGTH. AN ANTEGRADE APPROACH WAS USED, BUT THE SDS CATHETER WAS NOT HELD FLAT AND STRAIGHT OUTSIDE THE BODY, AND IT WAS NOTED THAT THE USER PUSHED FORWARD ON THE DEVICE DURING DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA 13391716

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK