BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 11886243 · Received May 26, 2021

    Report

    Report Number
    2029214-2021-00623
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    December 18, 2020
    Report Date
    May 26, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED PATIENT AGE (52 YEARS) IS REPRESENTATIVE OF THE MEAN AGE OF ALL PATIENTS INCLUDED IN THE STUDY, NOT NECESSARILY TO THE PATIENT WHO EXPERIENCED THE ADVERSE EVENTS. REPORTED PATIENT SEX (FEMALE) IS REPRESENTATIVE OF THE MAJORITY OF PATIENT INCLUDED IN THE STUDY POPULATION, NOT NECESSARILY TO THE PATIENT WHO EXPERIENCED THE ADVERSE EVENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ZHOU, Y., PENG, Q., WU, X., ZHANG, Y., LIU, J., YANG, X., & MU, S. (2020). ENDOVASCULAR TREATMENT OF TINY ANEURYSMS WITH LOW-PROFILE VISUALIZED INTRALUMINAL SUPPORT DEVICES USING A ¿COMPRESSED¿ STENT TECHNIQUE. FRONTIERS IN NEUROLOGY, 11, 610126. HTTPS://DOI .ORG/10.3389/FNEUR.2020.610126 MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND THAT 42 PATIENTS WERE TREATED FOR 42 TINY ANEURYSMS. THE PROCEDURES WERE COMPLETED UNDER GENERAL ANESTHESIA. AFTER SELECTING THE APPROPRIATE WORKING POSITION, A NON-MEDTRONIC MICROCATHETER WAS PLACED IN THE PARENT ARTERY GUIDED BY A MICROGUIDEWIRE. AN ECHELON-10 MICROCATHETER WAS THEN PLACED INTO THE ANEURYSM CAVITY. THE NON-MEDTRONIC STENT SYSTEM WAS THEN DELIVERED TO THE DISTAL END OF THE PARENT ARTERY. A COIL WAS PARTIALLY FILLED TO FORM THE FIRST HOOP, THEN THE STENT WAS THEN COMPLETELY RELEASED. WITH THE DISTAL END OF THE STENT FULLY ADHERED TO THE WALL, THE NON-MEDTRONIC MICROCATHETER WAS FIXED TO MAINTAIN TENSION WHILE COMPRESSING THE STENT, AND AFTER MAXIMUM STENT SHORTENING WITH COMPRESSION, THE STENT WAS SLOWLY RELEASED. FOR ANEURYSMS AT BIFURCATIONS OR WITH IMPORTANT BRANCHES NEAR THE NECK, THE STENT WAS RELEASED IN A "LANTERN-LIKE" SHAPE AFTER COMPRESSION SO THE DIAMETER OF THE STENT WAS WIDER AT THE ANEURYSM NECK AND MULTIPLE COILS MAY HAVE BEEN USED. ONE PATIENT INCLUDED IN THE STUDY WAS ORIGINALLY SCHEDULED FOR A SIMPLE COIL EMBOLIZATION PROCEDURE. HOWEVER, AFTER PLACING THE FIRST COIL, THE COIL PROLAPSED INTO THE PARENT ARTERY ABOUT 0.5CM. AT THAT POINT, IT WAS DECIDED TO IMPLANT THE STENT TO COMPRESS THE COIL AND PREVENT IT FROM MIGRATING COMPLETELY INTO THE PARENT ARTERY. AFTER ANESTHESIA, THE CALLOSOMARGINAL ARTERY WAS FOUND TO BE OCCLUDED DUE TO ACUTE THROMBOSIS DURING IMPLANTATION OF THE COIL MICROCATHETER. THE PATIENT RECEIVED IMMEDIATE THROMBOLYSIS TREATMENT AND THE CALLOSOMARGINAL ARTERY WAS RECANALIZED. AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH GRADE 2 MUSCLE STRENGTH ON ONE SIDE OF THE PATIENT'S BODY AND SPEECH DIFFICULTIES. COMPUTED TOMOGRAPHY (CT) OF THE HEAD SHOWED A LARGE FRONTAL PARIETAL INFARCTION. THE PATIENT'S MRS SCORE WAS 5 AT DISCHARGE. THERE WAS NO MALFUNCTION OF THE ECHELON MICROCATHETERS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779349 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ECHELON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other