BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1153450 · Received September 5, 2008

    Report

    Report Number
    9616099-2008-02160
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    December 27, 2007
    Report Date
    August 12, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    APPROXIMATELY NINE MONTHS POST INDEX PROCEDURE, A US DOPPLER OF THE LOWER LIMB ARTERIES (LEFT LEG) WAS CONDUCTED. BIPHASIC FLOW WAS DEMONSTRATED IN THE COMMON FEMORAL ARTERY. HOWEVER, THE STENT IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY WAS OCCLUDED THROUGHOUT ITS LENGTH. THE PT WAS INITIALLY ADMITTED FOR A PROCEDURE ON 03/20/.07 WITH A DE NOVO LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY, IN THE LEFT LEG. THE LESION WAS 22.2CM FROM THE SUPERIOR EDGE OF THE PATELLA AND WAS TOTALLY OCCLUDED. A SMART CONTROL NITINOL STENT WAS IMPLANTED TO TREAT THE LESION. THE PATIENT'S BASELINE MEDICATIONS INCLUDED ASPIRIN, CA ANTAGONIST, ACE INHIBITORS, DIURETICS, STATINS, MOXOMIDINE AND INSULIN. THE PT'S INTRA PROCEDURE MEDICATION INCLUDED ASPIRIN AND HEPARIN.

    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 Y0805299

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization A 1.5MM CORDIS GUIDEWIRE| A 5F CORDIS GUIDING CATHETER| A .035INCH TERUMO GUIDEWIRE| AN OPTAPRO BALLOON CATHETER| AN AMPLATZ GUIDEWIRE| A 4F CORDIS GUIDING CATHETER