BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1123849 · Received August 15, 2008

    Report

    Report Number
    1058196-2008-00200
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 9, 2008
    Report Date
    August 5, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDE H60001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE PT HAD A STROKE AND CAME OVER FROM ANOTHER COUNTRY, FOR TREATMENT. HE WAS FOUND TO HAVE STENOSIS OF HIS LEFT MI ARTERY (MOST LIKELY THE CAUSE OF HIS STROKE) ON OUR ANGIOGRAM. AT THAT TIME, TREATMENT OPTIONS WERE DISCUSSED AND AN ENTERPRISE STENT WAS PLACED TO ATTEMPT TO OPEN THIS VESSEL ON AN EMERGENCY BASIS AFTER CONSENT WAS OBTAINED. MIDDLE CEREBRAL ARTERY DISSECTION CAUSING AN ACUTE ISCHEMIC STROKE. THE MIDDLE CEREBRAL ARTERY WAS >90% NARROWED. CONSIDERATION TO PERFORM BALLOON ANGIOPLASTY, USE OF THE WINGSPAN STENT, AND AN INTRACRANIAL CORONARY STENT WERE CONSIDERED. HOWEVER, DUE TO THE UNDERLYING PATHOLOGY OF A VESSEL DISSECTION AND NOT ATHEROSCLEROSIS, IT WAS DEEMED MOST APPROPRIATE TO USE A SELF - EXPANDING INTRACRANIAL STENT FOR THERAPY. THE ENTERPRISE STENT WAS SUCCESSFULLY DEPLOYED WITHOUT COMPLICATIONS. PT TOLERATED THE PROCEDURE WELL. THE STENT DID NOT FULLY OPEN, AND THE NARROWING WAS ONLY REDUCED FROM >90% TO ABOUT 70%. A FOLLOW UP ANGIOGRAM HAS BEEN SCHEDULED IN 6-8 WEEKS.

    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 13357805

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR