BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1083487 · Received July 28, 2008

    Report

    Report Number
    9616099-2008-01700
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 30, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN.

    Description of Event or Problem · 1

    DURING A STENT PROCEDURE IN A STENOSED LEFT ILIAC ARTERY, AFTER PRE-DILATATION, THE SMART STENT WAS REPORTED TO HAVE JUMPED FORWARD DURING DEPLOYMENT, EVEN THOUGH ALL SLACK WAS REMOVED FROM THE DEPLOYMENT SYSTEM, AND THE PHYSICIAN WAS NOT HOLDING THE SHEATH IN A FIXED POSITION. A SECOND STENT HAD TO BE DEPLOYED TO SUFFICIENTLY COVER THE LESION. ACCORDING TO THE REPORTING AFFILIATE, THE SDS WAS HELD FLAT AND STRAIGHT DURING DEPLOYMENT. THERE WAS NO REPORT OF PT INJURY. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention