BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1101791 · Received August 5, 2008

    Report

    Report Number
    9616099-2008-01914
    Event Type
    Injury
    Date Received
    August 5, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 10, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MFR REPORT NUMBERS ARE 9616099-2008-0915 AND 9616099-2008-01917. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE NOTIFICATION RECEIVED FOR THE SUPER STUDY INDICATED THAT AN ATTEMPT TO PERFORM ANGIOPLASTY OF THE INDEX LIMB (DUPLEX DEMONSTRATES STENOSIS AT PROXIMAL AND DISTAL END OF SFA STENT) PERFORMED. HOWEVER, IT WAS NOT POSSIBLE TO OBTAIN ARTERIAL ACCESS AND PROCEDURE ABANDONED. SUCCESSFUL ANGIOPLASTY OF THE RIGHT SFA WAS PERFORMED AT SFA PROXIMAL TO STENTS AND IN-STENT STENOSIS. AT THIS TIME, THERE IS NO INFO REGARDING THE INDEX PROCEDURE. THE TARGET VESSEL WAS THE RIGHT SFA.

    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 13210702

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention