BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 896393 · Received August 13, 2007

    Report

    Report Number
    1058196-2007-00121
    Event Type
    Injury
    Date Received
    August 13, 2007
    Date of Event
    June 18, 2007
    Report Date
    July 14, 2007
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDE H60001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER OPERATOR REPORT, THE PT PRESENTED WITH SUDDEN ONSET OF WEAKNESS IN THE LEFT LOWER LIMB FOLLOWED BY RIGHT HEMIPARESIS AND WAS ADMITTED UNCONSCIOUS FOR SEVERAL DAYS. THE PT GRADUALLY WOKE UP AND RECOVERED, BUT HAD RESIDUAL RIGHT HEMIANOPIA. SERIAL BRAIN CT/MRI SHOWED LEFT MEDIAL THALAMIC HEMATOMA AND LARGE MEDIAL TEMPORO-OCCIPITAL INFARCT. THE DSA SHOWED A WIDE NECK FUSIFORM ANEURYSM OF THE LEFT PCA-BASILAR JUNCTION. THE FUNDUS IS DIRECTED DOWNWARD AND LATERALLY. THERE IS DUPLICATION OF THE LEFT SCA. BOTH THE SCA AND LEFT PCA ARISE FORM THE ANEURYSM. THE PT UNDERWENT THE STUDY TO DOCUMENT THE ANEURYSM AND PLACE THE ENTERPRISE STENT ACROSS THE ANEURYSM NECK. THE LEFT ICA AND BILATERAL VERTEBRAL ANGIOGRAMS WERE PERFORMED. THE ANEURYSM WAS WELL SEEN, AND IT WAS A WIDE NECK THAT AROSE FROM THE INFERO-LATERAL WALL OF THE DISTAL BASILAR ARTERY INCORPORATING THE ORIGINS OF THE LEFT PCA AND SCA. THE ANEURYSM HAS A SMOOTH WALL. THERE WERE SOME IRREGULARITIES OF THE BASILAR ARTERY BELOW THE SCA AND POSSIBLY AT THE SITE OF THE DISSECTION. THE LEFT PCA SHOWED AN OCCLUSION OF A SHORT SEGMENT ABOUT 1CM LONG BEYOND THE P2 SEGMENT. BEYOND THE PCA IT WAS REFORMED BY THIN COLLATERALS AND BEYOND THE CORTICAL BRANCHES WAS NORMAL. THE LEFT CAROTID ANGIOGRAM SHOWED NO PCA. IT WAS DECIDED TO USE AN ENTERPRISE SELF-EXPANDING STENT AS THE ANEURYSM WAS OF THE DISSECTING VARIETY AND NO COILS WOULD BE REQUIRED. ON PLACING THE STENT THERE BE VERY SMALL RESIDUAL PORTION OF THE ANEURYSM THAT WOULD NOT NEED COILS. A 6FRENCH SHEATH WERE PLACED IN BOTH FEMORAL ARTERIES. A 6FRENCH ENVOY GUIDING CATHETER WAS PLACED IN THE LEFT VERTEBRAL ARTERY AND LEFT AT C3. A TRANSCEND GUIDEWIRE AND PROWLER SELECT PLUS MICROCATHETER WAS ADVANCED ACROSS THE ANEURYSM INTO THE LEFT PCA. IN TRYING TO DEPLOY THE ENTERPRISE STENT, THE TRANSCEND GUIDEWIRE HAD TO BE PUSHED ACROSS THE OCCLUDED SEGMENT. THE 4.5X2MM ENTERPRISE STENT WAS DEPLOYED ACROSS THE NECK OF THE ANEURYSM FORM THE LEFT P1 TO THE DISTAL BASILAR ARTERY. THE PRODUCT REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR ANALYSIS. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING AN EMBOLIZATION PROCEDURE FOR A WIDE NECK ANEURYSM ON THE (MCA) MIDDLE CEREBRAL ARTERY, THE ENTERPRISE STENT WAS DEPLOYED AND UPON WITHDRAWAL OF THE CATHETER, AN INJECTION REVEALED A LEAK OF CONTRAST AROUND THE CATHETER INTO THE AMBIENT CISTERN. HEPARIN WAS NEUTRALIZED IMMEDIATELY WITH PROTAMINE (3ML) AND THE LEAK STOPPED ON ADVANCING THE CATHETER INTO THE PERFORATION. AN ULTRA-SOFT 2X6MM COIL WAS DEPLOYED AND DETACHED PARTLY IN THE SUB-ARACHNOID SPACE AND A PARTLY IN THE (PCA) POSTERIOR CEREBRAL ARTERY. AS THE LEAK PERSISTED ABOUT 0.3ML FOR 50% GLUE WAS INJECTED. THE LEAK STOPPED AFTER THIS TREATMENT. HOWEVER, THROMBUS WAS NOTED AROUND THE 4.5X22MM ENTERPRISE STENT. THE THROMBUS WAS TREATED WITH 10MG OF REOPRO. THE ANGIOGRAM SHOWED THAT THE ANEURYSM WAS SMALLER AND THERE WAS NO SPACE FOR ANY COILS. THERE WAS EXCELLENT FLOW IN THE BASILAR AND VERTEBRAL ARTERIES. ALL THE BRANCHES OF THE BASILAR ARTERY AND THEIR SMALLER BRANCHES WERE NORMAL. THE PT HAD NO NEUROLOGICAL DEFICIT.

    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 13162807

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening| R MICROCATHETER| 6FRENCH ENVOY CATHETER| EXCILCIOR| TRANSCEND GUIDEWIRE| ULTRASOFT COIL| 6FRENCH SHEATH| PROWLER MICROCATHETER