BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1127944 · Received August 20, 2008

    Report

    Report Number
    1058196-2008-00201
    Event Type
    Death
    Date Received
    August 20, 2008
    Date of Event
    June 2, 2008
    Report Date
    July 25, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDE H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVAL AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    PER OFF LABEL USE REQUIREMENTS A REPORT WAS RECEIVED INDICATING THAT THE PT WAS ADMITTED WITH A BASILAR ARTERY OCCLUSION AND WAS INTUBATED AND COMATOSE. THE PT UNDERWENT NUMEROUS ATTEMPTS AT RESTORATION OF FLOW TO THE VERTEBROBASILAR SYSTEM. MODALITIES USED INCLUDED ADMINISTRATION OF TPA, MERCY DEPLOYMENT, ANGIOPLASTY, AND INTRACRANIAL STENTING WITH AN ENTERPRISE VRD. AT THE COMPLETION OF THESE PROCEDURES, RESTORATION OF FLOW THROUGH THE VERTEBROBASILAR SYSTEM AS INJECTED FROM THE RIGHT VERTEBRAL ARTERY WAS NOT IMPROVED. THERE WAS HOWEVER IMPROVEMENT IN RETROGRADE FLOW ACROSS THE PCOMS AND DOWN THE BASILAR ARTERY INTO PORTION OF THE VERTEBRAL ARTERY SEGMENT. POST PROCEDURE, THE PATIENT'S NEUROLOGIC EXAM DID NOT IMPROVE. AN MRI SHOWED AN INFARCTION OF NEARLY THE FULL PONS. EEG SHOWED AN ALPHA COMA PATTERN. AFTER DISCUSSION WITH THE FAMILY, TEN DAYS POST PROCEDURE, THE GOALS OF CARE WERE CHANGED TO PROVIDING COMFORT MEASURES ONLY AND THE PT WAS EXTUBATED. THE PT EXPIRED THE NEXT DAY, 11 DAYS POST 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 13358603

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death UNKNOWN BALLOON ANGIOPLASTY| MERCY DEVICE