BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 13515579 · Received February 11, 2022

    Report

    Report Number
    2029214-2022-00203
    Event Type
    Injury
    Date Received
    February 11, 2022
    Date of Event
    September 13, 2021
    Report Date
    February 11, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LIU, Q., QI, C., WANG, Y., SU, W., LI, G., WANG, D. (2021). TREATMENT OF DIRECT CAROTID-CAVERNOUS FISTULA WITH WILLIS COVERED STENT WITH MIDTERM FOLLOW-UP. CHINESE NEUROSURGICAL JOURNAL, 7(1). HTTPS://DOI.ORG/10.1186/S41016-021-00256-Y. MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND THAT 10 CASES WERE COMPLETED WITH WILLIS COVERED STENT TO TREAT CAROTID-CAVERNOUS FISTULA (CCF). NAVIEN DISTAL ACCESS GUIDE CATHETERS WERE USED IN ALL CASES AND ECHELON 10 MICROCATHETER WAS USED IN ONE CASE. THERE WERE NO DEVICE MALFUNCTIONS REPORTED REGARDING THESE MEDTRONIC DEVICES AND NO PATIENT INJURIES RELATED TO THE MEDTRONIC CATHETERS. ONE CASE DESCRIBED IN THE ARTICLE WAS REGARDING A (B)(6) YEAR-OLD MALE PATIENT WHO WAS TREATED FOR TRAUMATIC CAROTID CAVERNOUS WITH COILS AND ONYX-18 IN A LOCAL HOSPITAL. THE SIGNED WERE RELIEVED AFTER THE PROCEDURE BUT THEN AGGRAVATED IN 10 DAYS BEFORE BEING TRANSFERRED TO THE STUDY HOSPITAL. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) CONFIRMED RECURRENCE OF THE CCF AND THE PATIENT WAS THEN SUCCESSFULLY TREATED WITH IMPLANTATION OF A WILLIS COVERED STENT. CLINICAL FOLLOW-UP AFTER THE PROCEDURE WITH THE WILLIS COVERED STENT AT 6 MONTHS POST-PROCEDURE AND 24 MONTHS POST-PROCEDURE SHOWED DISAPPEARANCE OF THE CCF BASELINE SYMPTOMS BUT DECREASED RIGHT VISUAL ACUITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111159 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 105-7000-060 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Required Intervention| H