BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1140559 · Received August 28, 2008

    Report

    Report Number
    9616099-2008-02115
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Report Date
    August 1, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. THE EVENT INFORMATION INDICATED THAT INTERVENTION WAS REQUIRED TO PREVENT PERMANENT IMPAIRMEMT; HOWEVER, AS OF YET NOT OTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED DURING AN ENDOVASCULAR PROCEDURE, THE PHYSICIAN HAD PROBLEMS WITH THE DEVICE; IT WAS REPORTED THAT THE INFORMATION ON THE LABEL OF THE SMART CONTROL NITINOL STENT SYSTEM INDICATED THE LENGTH OF THE DEVICE AS 120CM; HOWEVER, THE LENGTH WAS 150CM. THE PROBLEM WAS IDENTIFIED WHILE USING THE DEVICE IN THE PATIENT; AS A RESULT OF THE PROBLEM ANOTHER SMART CONTROL NITINOL STENT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM NONE NIM CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK