BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1181467 · Received September 30, 2008

    Report

    Report Number
    1058196-2008-00233
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    September 6, 2008
    Report Date
    September 9, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDEH60001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    STUDY. THIS FEMALE PT WITH HISTORY OF HUNT AND HESS GRADE II, WAS UNDERGOING AN ENTERPRISE STENT PLACEMENT WITHIN THE LEFT INTERNAL CAROTID SEGMENT/POSTERIOR COMMUNICATING ARTERY ANEURYSM, MEASURED H. 3MM X W 3MM, W, 2MM, NECK SIZE 3. PARENT VESSEL DIAMETER PROXIMAL TO ANEURYSM 5MM, DISTAL TO ANEURYSM 5MM. THE ANEURYSM WAS TREATED USING AN ENTERPRISE STENT 22 X 5 (LOT# 13394286). NO BALLOON WAS USED FOR VRD PLACEMENT. AFTER STENT PLACEMENT, TWO GDC 10 ULTRA SOFT COILS AND ONE GDC 10 SOFT COIL WAS PLACED WITHIN THE ANEURYSM. NO COMPLICATION OCCURRED. FOUR DAYS POST PROCEDURE THE PT HAD LEFT SUPERIOR LIMB THROMBO-PHLEBITIS AND ATRIAL FIBRILLATION, HEADACHE AND RIGHT HEMIPARESIS. ACTION WAS TAKEN WITH DRUG THERAPY. THE PT EXPIRED WITH HEART FAILURE. NO AUTOPSY WAS PERFORMED.

    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 13394286

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Life Threatening| D| R| H BARE BOSTON SCIENTIFIC GDC 10 SOFT| BARE BOSTON SCIENTIFIC GDC 10 ULTRA SOFT| BARE BOSTON SCIENTIFIC GDC 10 SOFT| BARE BOSTON SCIENTIFIC GDC 10 ULTRA SOFT