BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5812024 · Received July 21, 2016

    Report

    Report Number
    1226348-2016-00125
    Event Type
    Injury
    Date Received
    July 21, 2016
    Date of Event
    June 18, 2016
    Report Date
    June 30, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THREE OF THREE FINAL MDR REPORT BEING SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MFR# 2954740-2016-00160 AND 2954740-2016-00161. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE ENTERPRISE STENT CATALOG# ENF401612C, LOT# 10665773. 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. HEADACHE, REPRESENTED BY NEUROLOGIC SYMPTOMS AND INTRACRANIAL HEMORRHAGE ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE CODMAN EMBOLIC COILS AND THE ENTERPRISE STENT AND ARE LISTED IN THE IFUS AS SUCH. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT TARGET ANEURYSM ANATOMY, TARGET LESION OCCLUSION PERCENTAGE AND PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. COMMON DEVICE NAME CHANGED FROM "CNV ENTERPRISE SES (NJE)" TO "INTRACRANIAL NEUROVASCULAR STENT".

    Additional Manufacturer Narrative · 1

    THIS IS THREE OF THREE INITIAL MDR REPORTS BEING SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MFR# 2954740-2016-00160 AND 2954740-2016-00161. (B)(4). CONCOMITANT PRODUCT: UNKNOWN 5 FR MICROCATHETER; PROWLER SELECT PLUS MICROCATHETER (LOT UNKNOWN); ENVOY DA CATHETER (LOT UNKNOWN); BERENSTEIN GUIDING CATHETER; BENTSON GUIDEWIRE; AGILITY GUIDEWIRE. THE PRODUCT REMAINS IMPLANTED, AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. A DEVICE HISTORY RECORD REVIEW IS CURRENTLY BEING CONDUCTED AND THE RESULTS ARE NOT YET AVAILABLE. NO CONCLUSION IS MADE AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE ENTERPRISE IDE STUDY; SUBJECT (B)(6) WAS ENROLLED IN THE STUDY ON (B)(6) 2016. PRETREATMENT ANGIOGRAM PERFORMED ON (B)(6) 2016 REVEALED AN ANTERIOR CIRCULATION, SIDE WALL, SACCULAR ANEURYSM LOCATED ON THE LEFT SIDE WALL OF THE CAVERNOUS SEGMENT OF INTERNAL CAROTID ARTERY (ICA). THE SACCULAR ANEURYSM HAD A MAXIMUM DOME HEIGHT 2.4MM, DOME WIDTH 2.7MM AND DOME NECK 2.7; DOME TO NECK RATIO 1. DIAMETER OF THE PARENT VESSEL PROXIMAL AND DISTAL TO THE ANEURYSM WAS RECORDED AS 3.8MM. NO REPORT ON VESSEL TORTUOSITY RECORDED. BASELINE NIHSS OF 0, BASELINE MRS OF 0. PATIENT UNDERWENT STENT ASSISTED COILING ON (B)(6) 2016 WITH NO REPORTS OF INTRA-OPERATIVE COMPLICATIONS (THROMBOSIS, STENOSIS, AND VASOSPASM) OR DEVICE MALFUNCTIONS. ENTERPRISE STENT (ENF401612C/10665773), DELTAPLUSH COIL (DPL10015120/P11377) AND MICROSPHERE XL 10 COIL (SSR10025320/P11661) WERE THE DEVICES USED IN THE PROCEDURE. ANEURYSM WAS TREATED TO 90-99% OCCLUSION, RAYMOND SCORE 3 WITH RESIDUAL ANEURYSM. PATIENT WAS DISCHARGED ON (B)(6) 2016. ON (B)(6) 2016, SITE REPORTED PATIENT EXPERIENCED SHORTNESS OF BREATH, PNEUMONIA, HEADACHE AND ICH WITH A DATE OF ONSET (B)(6) 2016. EVENT OF SHORTNESS OF BREATH AND PNEUMONIA WERE REPORTED TO BE NON-NEUROLOGIC EVENTS. THESE EVENTS WERE REPORTED TO BE NEW, SEVERE AND SERIOUS ADVERSE EVENTS. THE EVENTS WERE REPORTED NOT RELATED TO THE CODMAN STUDY DEVICE OR OTHER DEVICES USED, NOT RELATED TO THE STUDY PROCEDURE AND NOT RELATED TO THE UNDERLYING DISEASE STATE. THE EVENTS WERE REPORTED TO BE RESOLVED WITH NO RESIDUAL EFFECTS WITH (B)(6) 2016 AS THE DATE OF RESOLUTION. ON (B)(6) 2016 PATIENT ALSO PRESENTED WITH HEADACHE AND LEFT CONVEXITY SUBARACHNOID HEMORRHAGE WHICH WERE REPORTED TO BE NEUROLOGIC EVENTS. THE EVENTS WERE REPORTED TO BE NEW, MODERATE SEVERITY AND SERIOUS ADVERSE EVENTS; NOT RELATED TO THE CODMAN STUDY DEVICE OR OTHER DEVICES USED, NOT RELATED TO THE STUDY PROCEDURE AND NOT RELATED TO THE UNDERLYING DISEASE STATE. THE EVENTS WERE REPORTED TO BE RESOLVED WITH NO RESIDUAL EFFECTS WITH (B)(6) 2016 AS THE DATE OF RESOLUTION. PATIENT WAS DISCHARGED ON (B)(6) 2016. STENT AND COIL REMAINS IMPLANTED. PRODUCTS ARE NOT AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466056 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC 10665773

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention