BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1033590 · Received April 23, 2008

    Report

    Report Number
    1058196-2008-00107
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 26, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDEH60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    ENTERPRISE STENT THROMBOSIS. THE PT WAS UNDERGOING STENT PLACEMENT AND COIL EMBOLIZATION OF THE CAROTID SYPHONE ANEURYSM. STENT THROMBOSIS ON ANEURISM NOT BLEEDING LOCATED IN SX CAROTID SYPHONE, OCCURRED A FEW HRS LATER AND ANOTHER DRUG'S THERAPY WAS STARTED WITH AGRASTADT 22 C + 3000 U OF HEPARIN FOLLOWED BY 1000 U/H + 7 CC OF AGRASTADT UNTIL 9 AM OF THE DAY AFTER THE PROCEDURE. THE PT'S CONDITION IS STABLE WITHOUT ANY CLINICAL SYMPTOMS. ANTIPLATELET THERAPY WAS STARTED ONE WEEK BEFORE THE STENT IMPLANT. THE DOUBLE ANTIPLATELET THERAPY WAS WITH FLECTADOL 300 MG STARTING DURING THE PROCEDURE, 3000 U OF HEPARIN, DURING THE PROCEDURE USED A HYPER GLIDE GUIDEWIRE 4 X 15 AND ECHELON 10, RT MICROCATHETER WITH ORBIT COILS PLACEMENT AND ENTERPRISE STENT IMPLANT. FLECTADOL 200 MG AND 2000 U OF HEPARIN WERE ADMINISTERED AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 13208704

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ECHELON 10| RT WITH ORBIT COILS| HYPERGLIDE 4 X 15