BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 7023067 · Received November 10, 2017

    Report

    Report Number
    1226348-2017-00188
    Event Type
    Injury
    Date Received
    November 10, 2017
    Date of Event
    August 1, 2017
    Report Date
    October 21, 2017
    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

    QIN F.; LI Z.; FANG X.; ET AL. (2017). THERAPEUTIC EFFECT OF ENTERPRISE STENT-ASSISTED EMBOLIZATION FOR VERY SMALL RUPTURED INTRACRANIAL ANEURYSMS. MEDICINE, 96 (34), 2017. ARTICLE NUMBER: E7832. 01 AUG 2017. DATE OF EVENT, PRODUCT CODE, AND LOT NUMBER COULD NOT BE OBTAINED FROM THE AUTHOR. UDI: UNKNOWN PART NUMBER, ATTEMPTS TO OBTAIN PRODUCT PART NUMBER WERE UNSUCCESSFUL, UDI UNAVAILABLE. CONCLUSION: THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. IN ADDITION, NO LOT NUMBER COULD BE OBTAINED; THEREFORE, A DHR COULD NOT BE PERFORMED FOR THE DEVICES. STENT STENOSIS IS A KNOWN POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM OR WITH THE PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THE IFU WARNS ¿EXPERIENCE WITH STENT IMPLANTS INDICATES THAT THERE IS A RISK OF STENOSIS¿. BASED ON THE INFORMATION PROVIDED IN THE ARTICLE, THE ROOT CAUSE OF THE EVENTS COULD NOT BE DETERMINED. NO ADDITIONAL INFORMATION COULD BE OBTAINED FROM THE AUTHOR OF THE STUDY. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENTS BASED ON REVIEWS OF COMPLAINT HISTORIES FOR THE DEVICES. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED IN A LITERATURE ARTICLE (QIN F.; LI Z.; FANG X.; ZHAO X.; LIU J.; WU D.; LAI N, ¿THERAPEUTIC EFFECT OF ENTERPRISE STENT-ASSISTED EMBOLIZATION FOR VERY SMALL RUPTURED INTRACRANIAL ANEURYSMS¿ PUBLISHED BY MEDICINE (UNITED STATES). 96 (34) (NO PAGINATION), 2017. ARTICLE NUMBER: E7832. DATE OF PUBLICATION: 01 AUG 2017), A PATIENT EXPERIENCED IN STENT STENOSIS FOLLOWING ENTERPRISE STENT-ASSISTED EMBOLIZATION (CATALOG AND LOT NUMBER NOT PROVIDED IN ARTICLE) AND NON-CODMAN COILS. THE (B)(6) FEMALE (PATIENT 27) PRESENTED WITH A RUPTURED 1.4 X 2.7 MM POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH A 2 MM NECK WIDTH. THERE WERE NO INTRA-PROCEDURE COMPLICATIONS; HOWEVER, THE PATIENT WAS LATER DIAGNOSED WITH IN STENT STENOSIS WITHOUT OBVIOUS CLINICAL SYMPTOMS. THERE WAS NO REPORT OF TREATMENT. THE RETROSPECTIVE STUDY AIMED TO EVALUATE THE SAFETY AND EFFICACY OF ENTERPRISE STENT-ASSISTED COILING EMBOLIZATION OF VERY SMALL RUPTURED INTRACRANIAL ANEURYSMS. A TOTAL OF 37 PATIENTS WITH RUPTURED VERY SMALL INTRACRANIAL ANEURYSMS WHO HAD ENTERPRISE STENT ASSISTED COIL EMBOLIZATION FROM FEBRUARY 2012 TO JULY 2016 WERE INCLUDED. ALL PATIENTS HAD CLINICAL MANIFESTATIONS OF SPONTANEOUS SUBARACHNOID HEMORRHAGE, WHICH WERE CONFIRMED BY CRANIAL CT. A SELECT PLUS MICROCATHETER WAS CONDUCTED THROUGH A MICROWIRE AND POSITIONED IN THE PARENT ARTERY PAST THE ANEURYSM NECK. THE ENTERPRISE STENT WAS ADVANCED THROUGH THE SELECT PLUS MICROCATHETER AND PLACED AT THE CEPHALIC END OF THE MICROCATHETER; HOWEVER, THE STENT WAS NOT RELEASED. AN ECHELON 10 MICROCATHETER (EV3 ENDOVASCULAR, INC.) WITH A VERY SMALL SHAPED TIP WAS INSERTED INTO THE ANEURYSMAL SAC OR NECK. ANEURYSMAL COILING WAS PERFORMED USING AN AXIUM 3D COIL (EV3 ENDOVASCULAR, INC.) OF APPROPRIATE DIAMETER AND LENGTH. AFTER 1 OR 2 COIL LOOPS WERE RELEASED TO FILL THE ANEURYSMAL CAVITY, THE STENT WAS SLOWLY RELEASED, AND THE RELEASE WAS STOPPED AFTER THE MICROCATHETER WAS FIXED AND THE COIL DID NOT PULSATE. THE ANEURYSMAL CAVITY WAS CONTINUOUSLY FILLED WITH THE COIL UNTIL 1¿2 CM OF THE COIL REMAINED INSIDE THE PARENT ARTERY. THE MICROCATHETER WAS REMOVED AFTER THE GUIDEWIRE-ACHIEVED STABILITY. AFTER THE POSITION OF THE COIL WAS STABILIZED, THE STENT WAS COMPLETELY RELEASED AND THE COIL WAS ISOLATED. THE ARTICLE CONCLUDED THAT THE ENTERPRISE STENT-ASSISTED COILING EMBOLIZATION CAN BE A SAFE AND EFFECTIVE TECHNIQUE FOR TREATMENT OF VERY SMALL RUPTURED INTRACRANIAL ANEURYSMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797586 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening