BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX

    MDR report key: 12776205 · Received November 8, 2021

    Report

    Report Number
    2029214-2021-01427
    Event Type
    Death
    Date Received
    November 8, 2021
    Date of Event
    February 10, 2021
    Report Date
    November 8, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LI Y, CHEN SH, GUNIGANTI R, ET AL. ONYX EMBOLIZATION FOR DURAL ARTERIOVENOUS FISTULAS: A MULTI-INSTITUTIONAL STUDY. JOURNAL OF NEURO INTERVENTIONAL SURGERY. FEBRUARY 2021. DOI:10.1136/NEURINTSURG-2020-017109. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LI Y, CHEN SH, GUNIGANTI R, ET AL. ONYX EMBOLIZATION FOR DURAL ARTERIOVENOUS FISTULAS: A MULTI-INSTITUTIONAL STUDY. JOURNAL OF NEURO INTERVENTIONAL SURGERY. FEBRUARY 2021. DOI:10.1136/NEURINTSURG-2020-017109. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH ONYX LIQUID EMBOLIC. THE PURPOSE OF THIS ARTICLE WAS TO CARRY OUT A MULTICENTER STUDY TO DETERMINE THE PREDICTORS OF COMPLICATIONS, OBLITERATION, AND FUNCTIONAL OUTCOMES ASSOCIATED WITH PRIMARY ONYX EMBOLIZATION OF DURAL ARTERIOVENOUS FISTULAS (DAVFS). A TOTAL 146 PATIENTS WERE INCLUDED (MEAN AGE 60, 59 PATIENTS WERE FEMALE). THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED:  - THERE WERE 4 INSTANCES OF PATIENT DEATH, THREE OF WHICH WERE SAID TO BE DAVF-RELATED. NONE OF THESE WERE ATTRIBUTED TO PROCEDURAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674245 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Death