BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 14212380 · Received April 26, 2022

    Report

    Report Number
    2029214-2022-00715
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    December 20, 2021
    Report Date
    April 26, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    UDI-DI
    00847536006171
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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

    MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD A WORSENING COGNITIVE DECLINE. THE PATIENT WAS FORGETFUL AND CONFUSED WHEN ADMITTED TO THE HOSPITAL. THE MWS OF 2 WAS IMPROVED TO A 1 24 HOUR POST OPERATIVE, BUT WORSENED TO A 3 UPON DISCHARGE, WHICH WAS ONE DAY PRIOR TO THE 14 DAY WINDOW. THE PATIENT EXPERIENCED AN INCREASED CONFUSION, DELUSIONS, AND AGITATION SINCE THE PROCEDURE. THE PATIENT HAS ALSO SHOWN AGGRESSIVE BEHAVIOR. THE PATIENT WAS ADMITTED FROM (B)(6) 2022 TO (B)(6) 2022 DUE TO ALTERED MENTAL STATUS, WHICH FOUND THE PATIENT HAD OTHER ISSUES OF ACUTE CYSTITIS AND COVID. THE SITE RELATED ASSESSMENT DETERMINED THE EVENT TO BE NOT RELATED TO THE PROCEDURE AND THE DEVICE. THE SPONSOR ASSESSMENT DETERMINED THE EVENT WAS POSSIBLY RELATED TO THE EMBOLIZATION PROCEDURE. THE SUBJECT HAD UNDERLYING DEMENTIA, WHICH WAS EXACERBATED BY THE EMBOLIZATION PROCEDURE AND SURGICAL EVACUATION. THE PATIENT WAS RECOVERING AT THE TIME OF THE REPORT. THE SDH LOCATION WAS FRONTAL, PARIETAL. THE HEMATOMA THICKNESS WAS 16MM AND THE MIDLINE SHIFT WAS 2MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513634 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 105-7100-060 B283487 00847536006171

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Hospitalization