BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5506379 · Received March 16, 2016

    Report

    Report Number
    1058196-2016-00056
    Event Type
    Injury
    Date Received
    March 16, 2016
    Date of Event
    November 2, 2015
    Report Date
    February 19, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) IS CURRENTLY BEING REVIEWED. THE RESULTS OF THE REVIEW WILL BE REPORTED WITHIN 30 DAYS. NO CONCLUSIONS ARE AVAILABLE AT THIS TIME. (B)(4). THIS REPORT IS RELATED TO MFR REPORT # 1058196-2016-00057.

    Additional Manufacturer Narrative · 1

    LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE ABOVE MENTIONED LOT. 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. BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; HOWEVER A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THROMBOEMBOLISM IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD DEVICE AND IS LISTED IN THE IFU 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 INFORMATION SUGGESTS THAT TARGET LESION, PATIENT FACTORS AND MEDICATION REGIMEN MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿SAFETY AND EFFICACY OF A NEW PROPHYLACTIC TIROFIBAN PROTOCOL WITHOUT ORAL INTRAOPERATIVE ANTIPLATELET THERAPY FOR ENDOVASCULAR TREATMENT OF RUPTURED INTRACRANIAL ANEURYSMS¿ BY XIAO-DONG LIANG, ZI-LIANG WANG, TIAN-XIAO LI, YING-KUN HE, WEI-XING BAI, YANG-YANG WANG, GUO-YU ZHOU PUBLISHED J NEUROINTERVENT SURG 2015;0:1¿6. DOI:10.1136/NEURINTSURG-2015-012055 IT WAS REPORTED THAT A FEMALE (B)(6) YEAR-OLD PATIENT SUFFERED A THROMBOEMBOLISM AFTER TWO ENTERPRISE STENTS (ENC452212/10367365) WERE IMPLANTED. THERE WERE NO DEVICE ISSUES AND THE DEVICES WERE SUCCESSFULLY IMPLANTED. THE IMPLANTATION WAS INTENDED TO ACHIEVE A DENSE EMBOLIZATION OF AN ANEURYSM LOCATED AT THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY. IN THE ARTICLE IS STATES THAT COIL EMBOLIZATION OF INTRACRANIAL ANEURYSMS IS BEING INCREASINGLY USED; HOWEVER, THROMBOEMBOLIC EVENTS HAVE BECOME A MAJOR PERIPROCEDURAL COMPLICATION. TIROFIBAN WAS ADMINISTERED AS AN INTRAVENOUS BOLUS (8.0 μG/KG OVER 3 MIN) FOLLOWED BY A MAINTENANCE INFUSION (0.10 μG/KG/MIN) BEFORE STENT DEPLOYMENT OR AFTER COMPLETION OF SINGLE COILING. DUAL ORAL ANTIPLATELET THERAPY (LOADING DOSES) WAS OVERLAPPED WITH HALF THE TIROFIBAN DOSE 2 H BEFORE CESSATION OF THE TIROFIBAN INFUSION. CASES OF INTRACRANIAL HEMORRHAGE OR THROMBOEMBOLISM WERE RECORDED. NO SPECIFIC TREATMENT WAS REPORTED FOR THIS EVENT AND THE PATIENT WAS NOTED TO BE DISCHARGED WITH AN MRS SCORE OF 4, AND AN MRS SCORE OF 0 AT 3 MONTHS. THERE WERE NO PROCEDURAL DIFFICULTIES AND THE PHYSICIAN HAD AT LEAST 4 YEARS OF EXPERIENCE PERFORMING NEURO-INTERVENTIONAL PROCEDURES. ACCORDING TO THE AUTHOR, THE MAJOR CAUSE OF THE EVENT IS UNCERTAIN BUT MAY HAVE BEEN DUE TO LOW RESPONSE TO THE ANTIPLATELET MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160279 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC 10367365

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R