BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1220549 · Received November 4, 2008

    Report

    Report Number
    1058196-2008-00263
    Event Type
    Injury
    Date Received
    November 4, 2008
    Report Date
    October 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: LAKE REGION LOT NUMBER IS CORDIS LOT NUMBER. PER LAKE REGION REPORT: CORDIS NEUROVASCULAR REPORTED NO PRODUCT IS EXPECTED TO BE RETURNED TO LAKE REGION MEDICAL FOR EVAL; HOWEVER, A COPY OF THE INVESTIGATION REQUESTED INCLUDING LOT TRACEABILITY WAS PROVIDED. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVAL, LAKE REGION MEDICAL IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING. THIS PACKAGING LOT CONTAINED 24 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON 12/21/07. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE PT UNDERWENT SUCCESSFUL DEPLOYMENT OF THE CORDIS ENTERPRISE STENT ACROSS A RIGHT SUPRACLINOID INTERNAL CAROTID ARTERY ANEURYSM. AFTER PLACEMENT, NORMAL ANTEGRADE FILLING WITHIN THE RIGHT OPHTHALMIC ARTERY WAS NOTED. THE PT WAS SEEN ONE MONTH LATER AND REPORTED NO NEUROLOGICAL SYMPTOMS. SHE WAS SCHEDULED FIVE MONTHS LATER FOR EMBOLIZATION OF THE ANEURYSM THROUGH THE STENT. CEREBRAL ANGIOGRAPHY WAS PERFORMED PRIOR TO EMBOLIZATION DEMONSTRATED RIGHT OPTHALMIC OPACIFICATION IN AN ANTEGRADE FASHION FILLING FROM THE EXTERNAL CAROTID ARTERY CIRCULATION. THIS FILLING SUGGESTS ASYMPTOMATIC OCCLUSION OF THE CIRCULATION OF THE OPHTHALMIC ARTERY FROM THE INTERNAL CAROTID ARTERY THAT TOOK PLACE SOMETIME AFTER THE PLACEMENT OF THE STENT. SHE REMAINED NEUROLOGICALLY INTACT WITH NO REPORTED VISUAL CHANGES POST EMBOLIZATION. PATIENT'S OPHTHALMIC ARTERY WAS TINY, BUT HAD DUAL SUPPLY IDENTIFIED ON PRE ANGIO FROM EXTERNAL CAROTID ARTERY. KNOWN RISK OF CLOSED CELL DESIGN STENTING, ESPECIALLY AROUND CURVED SMALL ARTERIES. THIS (PROTECTIVE) STENT WAS DEEMED PRE-OP SAFER THAN CONVENTIONAL NEUROLOSURGICAL APPROACH. VISION WITHOUT CHANGE.

    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 13301935

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR