BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5494745 · Received March 11, 2016

    Report

    Report Number
    1058196-2016-00035
    Event Type
    Injury
    Date Received
    March 11, 2016
    Date of Event
    April 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

    THIS FOUR OF FIVE INITIAL/FINAL REPORT FOR THIS COMPLAINT (B)(4) WITH ASSOCIATED MDR REPORT NUMBERS OF 1058196-2016-00031, 1058196-2016-00032, 1058196-2016-00033 AND 1058196-2016-00036. UDI UNKNOWN PART NUMBER, ALL 3 ATTEMPTS TO OBTAIN PRODUCT WERE UNSUCCESSFUL, UDI UNAVAILABLE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED BECAUSE THE LOT FOR THE PRODUCT IS UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN WANG ET AL (2015, APR 02) APPLICATION OF THE ENTERPRISE STENT IN ATHEROSCLEROTIC INTRACRANIAL ARTERIAL STENOSIS: A SERIES OF 60 CASES. TURK NEUROSURG 26(1):69-76. DOI: 10.5137/1019-5149.JTN.13350-14.1.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE "APPLICATION OF THE ENTERPRISE STENT IN ATHEROSCLEROTIC INTRACRANIAL ARTERIAL STENOSIS: A SERIES OF 60 CASES" BY XIAOFEI WANG, ZHIGANG WANG, CHENGWEI WANG, YONG JI1, XUAN DING AND YIZHENG ZANG, PUBLISHED TURK NEUROSURG 26(1):69-76, 2016, DOI: 10.5137/1019-5149.JTN.13350-14.1, IT WAS REPORTED THAT OF THE 60 PATIENTS, ONLY 5 (8.3%) HAD PERIOPERATIVE COMPLICATIONS ( WITHIN 30 DAYS OF THE INDEX PROCEDURE). THERE WAS ONE CASE OF IN-STENT THROMBOSIS, ONE CASE OF IN-STENT DISSECTION, ONE CASE OF INTRAOPERATIVE VERTEBRAL ARTERY SPASM AND, TWO PATIENTS HAD ISCHEMIC STROKES WITHIN 30 DAYS POSTOPERATIVELY, NOT ASSOCIATED WITH INSTENT STENOSIS. WE ASSESSED THE SAFETY AND EFFECTIVENESS OF THE ENTERPRISE STENT IN TREATING ATHEROSCLEROTIC INTRACRANIAL ARTERIAL STENOSIS (AIAS). THIS WAS A RETROSPECTIVE STUDY CONDUCTED WITH 60 CONSECUTIVE PATIENTS WITH 62 AIAS LESIONS WHO RECEIVED THE ENTERPRISE STENT AT THE DEPARTMENT OF NEUROSURGERY, SECOND HOSPITAL OF SHANDONG UNIVERSITY BETWEEN JUNE 2012 AND JANUARY 2014. ALL PATIENTS WERE ASSESSED USING THE MODIFIED RANKIN SCORING SYSTEM AT DISCHARGE. CLINICAL FOLLOW-UPS AND DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WERE PERFORMED AT 1, 3, 6 AND 12 MONTHS POSTOPERATIVELY. APPLICATION OF THE ENTERPRISE STENT WAS SAFE AND EFFICACIOUS. THE TECHNICAL SUCCESS RATE WAS HIGH WHILE THE PERIOPERATIVE COMPLICATION RATE WAS LOW. AT THE TIME OF COMPLAINT ENTRY NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE. THIS REPORT FOR ONE PATIENT WITH ISCHEMIC STROKE WITHIN 30 DAYS POSTOPERATIVELY, NOT ASSOCIATED WITH INSTENT STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150783 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GATEWAY BALLOON (BOSTON SCIENTIFIC)