BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1844876 · Received September 27, 2010

    Report

    Report Number
    9616099-2010-00719
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 31, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K042969
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT HAS BEEN RECEIVED FOR EVALUATION. HOWEVER, THE ENGINEERING ANALYSIS IS NOT YET COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED IN 30 DAYS.

    Description of Event or Problem · 1

    THE STENT DISLODGED WHILE IT WAS DEPLOYED.

    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 15093198

    Patients

    Seq Age Sex Outcome Treatment
    1