BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2221835 · Received August 24, 2011

    Report

    Report Number
    1058196-2011-00425
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    March 15, 2011
    Report Date
    August 10, 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

    IT WAS REPORTED VIA THE (B)(4) POST MARKET STUDY THAT THE DAY AFTER AN ENTERPRISE VRD ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED LEFT POSTERIOR COMMUNICATING (PCOM) ARTERY ANEURYSM THE (B)(6) PATIENT DEVELOPED PARALYSIS IN THE RIGHT UPPER LIMP. MRI ALSO REVEALED CEREBELLAR INFARCTION IN LEFT CEREBRAL HEMISPHERE. NO ACTION WAS TAKEN. THE OUTCOME OF THE EVENTS WAS NOTED AS RESOLVED NINE DAYS POST PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN COMMENTED THAT THE EVENTS WERE UNRELATED TO THE ENTERPRISE. THE PATIENT HAD NO NEUROLOGICAL DEFICITS PRIOR TO THE PROCEDURE AND THERE WAS NO THROMBUS PRESENT AT THE SITE. AFTER PLACEMENT THE ENTERPRISE STENT WAS FULLY EXPANDED, APPOSE TO THE WALL, AND IN STABLE POSITION WITHOUT THROMBUS AT THE SITE. THE RATE OF ANEURYSM OCCLUSION WAS 90% POST COILING USING SIX COILS. THERE WERE NO COILS PROTRUDING FROM THE ANEURYSM. AFTER THE STENT AND COILING PROCEDURE WAS COMPLETED, NO THROMBUS OR OTHER ISSUES WERE NOTED AT THE SITE. THE ANEURYSM MEASURED 5.4MM AT THE NECK WITH A NECK TO SAC RATIO OF 5.4MMX6.7MM. THE PARENT VESSEL DIAMETER PROXIMALLY WAS 2.9MM AND DISTALLY WAS 3,5MM. ANTIPLATELET THERAPY INCLUDED DAILY ASA AND CLOPIDOGREL BEGINNING THREE DAYS PRE-PROCEDURE. BASELINE ACT WAS 124 SECONDS, HEPARIN 5000 UNITS WAS ADMINISTERED DURING THE PROCEDURE WITH AN ACT OF 303 SECONDS POST ANTICOAGULATION. BASELINE (B)(6) WAS 0, MRS 5 DAYS POST PROCEDURE WAS 1 AND ONE MONTH POST PROCEDURE (B)(6) WAS 0. NO PROCEDURAL/DIAGNOSTIC IMAGES ARE AVAILABLE. THE ENTERPRISE VRD REMAINS IMPLANTED. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01426711. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, 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 AND NEUROLOGICAL SYMPTOMS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM IN THE INTRACRANIAL ARTERIES 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 MAY RESULT IN EMBOLIZATION OF DEBRIS FROM THE INTIMAL LAYERS OF THESE ARTERIES. ALTHOUGH BASED ON THE AVAILABLE INFORMATION AND WITHOUT PROCEDURAL/DIAGNOSTIC IMAGES, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE EVENTS AND THE ENTERPRISE VRD. THE CAUSE OF THE EVENT CANNOT BE DETERMINED; HOWEVER, PATIENT, PROCEDURAL AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED. THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PRODUCTS UTILIZED DURING THE PROCEDURE CONSISTED OF SHUTTLE SHEATH GUIDING CATHETER (COOK INC), PROWLER SELECT PLUS MICROCATHETER (606-S255X/LOT# UNKNOWN), CHIKAI GUIDEWIRE (ASAHI INTECC), TRANSEND 300 GUIDEWIRE (BOSTON SCIENTIFIC), EXCELSIOR SL-10 MICROCATHETER (BOSTON SCIENTIFIC-X 2), MATRIX2 COILS X3 (BOSTON SCIENTIFIC), AND GDC 10 COILS X3 (BOSTON SCIENTIFIC). THE ANTIPLATELET THERAPY CONSISTED ASPIRIN 100MG/DAY: (B)(6) 2011, CLOPIDOGREL SULFATE 75MG/DAY: (B)(6) 2011, AND HEPARIN 5000U: (B)(6) 2011 (DURING THE PROCEDURE). THE UNRUPTURED SACCULAR ANEURYSM MEASUREMENT WAS 5.4MM AT NECK AND THE NECK TO SAC RATION WAS 5.4MMX6.7MM. THE PARENT VESSEL DIAMETER PROXIMALLY WAS 2.9MM AND DISTALLY WAS 3,5MM. A CD COPY OF THE PROCEDURE WAS NOT AVAILABLE, AND THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS REPORT FROM THE CLINICAL STUDY (B)(4) FOR PATIENT WITH ID (B)(4) INDICATED THAT THE PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH AN ENTERPRISE VRD (ENC452812/ 01426711) OF THE LEFT POSTERIOR COMMUNICATING ARTERY, AND THE DAY AFTER THE PROCEDURE THE PATIENT DEVELOPED PARALYSIS IN RIGHT UPPER LIMB. MRI ALSO REVEALED CEREBELLAR INFARCTION IN LEFT CEREBRAL HEMISPHERE. NO ACTION WAS TAKEN, AND AS TWO WEEKS FROM ONSET, THE OUTCOME OF BOTH EVENTS WAS NOTED AS RESOLVED. THE PHYSICIAN'S COMMENTED THAT THE RELATIONSHIP OF BOTH EVENTS TO THE ENTERPRISE WAS UNRELATED. IT IS UNKNOWN IF THE STENT WAS PATENT DURING THE EVENT. THE PATIENT WAS NOT ADMITTED WITH NEUROLOGICAL DEFICITS, AND PRIOR TO THE PROCEDURE, THROMBUS WAS NOT NOTED AT THE SITE. AFTER THE STENT AND COILING PROCEDURE WAS COMPLETED, NO THROMBUS OR OTHER ISSUES WAS NOTED AT THE SITE. AFTER PLACEMENT, THE ENTERPRISE STENT WAS FULLY EXPANDED, APPOSED TO THE VESSEL WALL AND IN A STABLE POSITION, AND THE OCCLUSION RATE OF ANEURYSM WAS 90% AFTER THE PROCEDURE. NO COIL WAS PROTRUDING INTO THE PARENT ARTERY.

    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 01426711

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| S