BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2073368 · Received May 1, 2011

    Report

    Report Number
    1058196-2011-00191
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    February 10, 2011
    Report Date
    April 8, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS TO SERVE AS NOTIFICATION OF THE FOLLOWING: THIS IS ONE OF MULTIPLE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORTS 1058196-2011-00191, 1058196-2011-00192, 1058196-2011-00193, 3007628272-2011-50011, 1058196-2011-00255, 1058196-2011-00256, 1058196-2011-00257, 1058196-2011-00258, 1058196-2011-00259, 1058196-2011-00260, 1058196-2011-00261, 1058196-2011-00262, 1058196-2011-00263, 1058196-2011-00264, 1058196-2011-00265, 1058196-2011-00266, 3007628272-2011-50013, AND 3007628272-2011-50014.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PROWLER SELECT PLUS MICROCATHETER, ROAD MASTER 7FRENCH GUIDING CATHETER, EXCELSIOR SL10 MICROCATHETER, CHIKAI GUIDEWIRE, ORBIT TDL (QTY 10), ORBIT COMPLEX FILL (QTY 20), HYDRO COIL (QTY 7), AND GALAXY COILS (QTY 12). THE PRE-PROCEDURE ACT WAS 144 SECONDS, AND POST-PROCEDURE WAS 266 SECONDS. MEDICATIONS CONSISTED OF PLAVIX 75MG/DAY (B)(6), HEPARIN (INTRA-PROCEDURE), AND CILOSTAZOL 100MG/DAY (B)(6). THE SACCULAR ANEURYSM MEASURED AT THE NECK WAS 7.0MM AND THE NECK TO SAC RATIO WAS 7.0MM/9.7MM. THE TARGET SITE WAS THE RIGHT PARASELLAR WITH A VESSEL DIAMETER PROXIMALLY 4.4MM AND DISTALLY 3.8MM. A CD COPY OF THE PROCEDURE IS NOT AVAILABLE. NO FURTHER INFORMATION WAS AVAILABLE. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF ENTERPRISE LOT 01422609. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM (B)(4), ALONG WITH LAKE REGION MEDICAL'S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. CEREBRAL INFARCTION/STROKE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM AND COIL EMBOLIZATION PROCEDURES AS OUTLINED IN THE INSTRUCTIONS FOR USE. DURING INTERVENTIONAL PROCEDURES, THE DEVICES ARE ADVANCED AND WITHDRAWN THROUGH ACCESSORY ARTERIES TO TREAT THE TARGET LESION. THE PHYSICAL MANIPULATION OF THE ARTERIES AND IN THIS CASE, THE PRE-EXISTING PRESENCE OF THROMBUS IN THE ANEURYSM MAY RESULT IN EMBOLIZATION FROM THE TREATMENT SITE. IT APPEARS THAT CLINICAL FACTORS CONTRIBUTED TO THE EVENT WITH NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF MULTIPLE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2011-00191, 1058196-2011-00192, 1058196-2011-00193, AND 3007628272-2011-50011.

    Description of Event or Problem · 1

    THE (B)(4) STUDY INDICATED THAT THE PATIENT WITH ID (B)(4) DEVELOPED A STROKE (INFARCTION) IN THE RIGHT BRAIN AN HOUR AFTER THE PROCEDURE COIL EMBOLIZATION ASSISTED WITH AN ENTERPRISE STENT (ENC452212). ADDITIONALLY, THE PATIENT HAD HEMIPLEGIA (LEFT UPPER LIMB) AND SPACIAL NEGLECT WAS NOTED. DRUG THERAPY WAS DONE WITH RADICUT, ARGATROBAN AND HEPARIN. RECOVERY WAS CONFIRMED. (DATE UNKNOWN). THE PHYSICIAN COMMENTED THE THROMBUS MIGHT COME OUT OF THE ANEURYSM. THE MODIFIED RANKIN SCALE PRE-PROCEDURE WAS 3, POST (WITHIN A WEEK) WAS 4, AND POST (AFTER 30 DAYS) WAS 3. PRIOR OR DURING THE PROCEDURE, THROMBUS WAS NOTED AT THE SITE AND PARTIALLY IN THE ANEURYSM. THE ENTERPRISE WAS FULLY EXPANDED AND APPOSED TO THE VESSEL WALL AFTER INITIAL PLACEMENT, AND THE ENTERPRISE WAS FULLY EXPANDED, APPOSED TO THE VESSEL WALL AND IN A STABLE POSITION AS COMPARED TO POSITION AFTER PLACEMENT. THERE WERE NO INDICATIONS OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE.

    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 01422609

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention