BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5506378 · Received March 16, 2016

    Report

    Report Number
    1058196-2016-00055
    Event Type
    Malfunction
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) IS CURRENTLY BEING REVIEWED. NO CONCLUSIONS ARE AVAILABLE AT THIS TIME. THE RESULTS OF THE REVIEW WILL BE REPORTED WITHIN 30 DAYS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) 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. IT SHOULD BE NOTED THAT THE REPORTED LOT HAS A USE BY DATE OF 2014-06, AS INDICATED IN THE DEVICE HISTORY RECORDS. THROMBOEMBOLISM, IN THIS CASE ASSOCIATED WITH COIL PROTRUSION, IS A KNOWN POTENTIAL ADVERSE VENT 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 AVAILABLE INFORMATION SUGGESTS THAT TARGET LESION AND PARENT VESSEL CHARACTERISTICS, PATIENT, MEDICATION AND PROCEDURAL FACTORS 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) PATIENT SUFFERED A THROMBOEMBOLISM AFTER AN ENTERPRISE STENT (ENC452212/10151076) WAS IMPLANTED. THERE WERE NO DEVICE ISSUES AND THE DEVICE WAS SUCCESSFULLY IMPLANTED. THE IMPLANTED EMBOLIC COILS PROTRUDED INTO THE PARENT INTERNAL CAROTID ARTERY PRIOR TO THE IMPLANTATION. 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 MICRO G/KG OVER 3 MIN) FOLLOWED BY A MAINTENANCE INFUSION (0.10 MICRO G/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. AT THE TIME OF COMPLAINT ENTRY NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE. 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
    160185 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC 10151076

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R