BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6685443 · Received July 4, 2017

    Report

    Report Number
    1226348-2017-00090
    Event Type
    Injury
    Date Received
    July 4, 2017
    Date of Event
    May 29, 2013
    Report Date
    June 11, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS INITIAL/FINAL MDR REPORT SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MFR CODE# 1226348-2017-00090. LITERATURE ARTICLE IS ATTACHED TO THIS REPORT. THIS SUBMISSION IS RELATED TO A LITERATURE ARTICLE DISCOVERED IN AN EFFORT TO SUPPORT THE CER SUBMISSION PROCESS, AS SUCH, THE ASSOCIATED TIME FRAME OF EVENT DATES INCLUDES BUT IS NOT LIMITED TO 20 YEARS. THESE ARTICLES ARE BEING REVIEWED ON A MONTHLY BASIS FOR SAFETY SIGNALS AND WILL BE FOLLOWED BY MONTHLY TRENDING ASSESSMENTS AS WELL AS PMS REVIEWS. THERE ARE NO ALLEGED QUALITY ISSUES WITH THE PRODUCT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED BECAUSE THE LOT FOR THE PRODUCT IS UNKNOWN. SINCE THERE IS NO EVIDENCE OF A MANUFACTURING-RELATED MALFUNCTION, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. NO DEVICE RETURNED TRANSIENT ISCHEMIC ATTACK AND CEREBRAL INFARCTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE CODMAN ENTERPRISE SES DEVICE AND IS LISTED IN THE IFU AS NEUROLOGIC DEFICITS. ALTHOUGH THERE IS NOT PRODUCT SPECIFIC INFORMATION AVAILABLE, 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 SITE/ PARENT VESSEL ANATOMY AND MEDICATION REGIMEN MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE "TRIPLE ANTIPLATELET THERAPY WITH ADDITION OF CILOSTAZOL TO ASPIRIN AND CLOPIDOGREL FOR Y-STENT-ASSISTED COIL EMBOLIZATION OF CEREBRAL ANEURYSMS" BY KENICHI KONO & AKI SHINTANI & RYO YOSHIMURA & HIDEO OKADA & YUKO TANAKA & TAKESHI FUJIMOTO & NAGATSUKI TOMURA & TOMOAKI TERADA, PUBLISHED ACTA NEUROCHIR (2013) 155:1549-1557 DOI 10.1007/S00701-013-1771-4, IT WAS REPORTED THAT AN UNKNOWN PATIENT HAD ADVERSE EVENTS OF TIA AND CEREBRAL INFARCTION POST UNKNOWN ENTERPRISE STENT IMPLANTATION. PER THE ARTICLE: "DUAL ANTIPLATELET THERAPY FOR STENT-ASSISTED COILING OF CEREBRAL ANEURYSMS IS ESSENTIAL TO PREVENT THROMBOEMBOLIC COMPLICATIONS. THERE IS CONCERN THAT Y-STENT-ASSISTED COILING MAY INCREASE THROMBOEMBOLIC COMPLICATIONS COMPARED WITH COILING WITH A SINGLE STENT. SEVERAL REPORTS HAVE DEMONSTRATED THAT CILOSTAZOL MAY IMPROVE CLOPIDOGREL RESPONSIVENESS. WE INVESTIGATED WHETHER TRIPLE ANTIPLATELET THERAPY WITH ADDITION OF CILOSTAZOL TO ASPIRIN PLUS CLOPIDOGREL FOR Y-STENTS CAN PREVENT THROMBOEMBOLIC EVENTS. .... ALTHOUGH THE NUMBER OF PATIENTS IN THE Y-STENT GROUP IS SMALL, THIS GROUP HAD A SIGNIFICANTLY HIGHER RISK OF THROMBOEMBOLIC COMPLICATIONS. WHILE OUR PROTOCOL OF A ROUTINE DOSE OF DUAL ANTIPLATELET THERAPY MAY BE SUFFICIENT FOR SINGLE STENT THERAPY, OUR PROTOCOL OF A ROUTINE DOSE OF TRIPLE ANTIPLATELET THERAPY FOR Y-STENTS MAY NOT PREVENT THROMBOEMBOLIC EVENTS. THIS SUGGESTS THAT EVALUATION OF PLATELET FUNCTION MAY BE ESSENTIAL, ESPECIALLY FOR Y-STENTS...." INFARCTION AND TIA OCCURRED IN PATIENT # 24 IN THE Y-STENT GROUP . JUST AFTER THE PROCEDURE, THE PATIENT SHOWED SLIGHT MEMORY DISTURBANCE BECAUSE OF LEFT TEMPOROMEDIAL INFARCTION (FIG. 1D), WHICH WAS RESOLVED IN 3 DAYS." CILOSTAZOL WAS WITHDRAWN 1 WEEK AFTER THE PROCEDURE. ON THE NEXT DAY, THE PATIENT SHOWED SUDDEN CONSCIOUSNESS DISTURBANCE. MRI SHOWED NO HEMORRHAGE OR ACUTE INFARCTION. ARGATROBAN WAS ADMINISTERED. THE PATIENT'S CONSCIOUSNESS SOON RECOVERED FOLLOWING THIS ADMINISTRATION. FOLLOW-UP MRI SHOWED NO ADDITIONAL INFARCTION. CILOSTAZOL WAS RESUMED, AND TRIPLE ANTIPLATELET THERAPY WAS CONTINUED. THE PATIENT WAS DISCHARGED WITH A MODIFIED RANKIN SCALE OF 0. ASPIRIN WAS CAREFULLY WITHDRAWN 6 MONTHS AFTER TREATMENT. DOUBLE ANTIPLATELET AGENTS, CLOPIDOGREL AND CILOSTAZOL WERE CONTINUED, AND THE PATIENT REMAINED NEUROLOGICALLY INTACT 19 MONTHS AFTER THE PROCEDURE. AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465819 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention