BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 12788608 · Received November 10, 2021

    Report

    Report Number
    2029214-2021-01440
    Event Type
    Injury
    Date Received
    November 10, 2021
    Date of Event
    June 29, 2020
    Report Date
    November 10, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    BRINJIKJI, W., CLOFT, H. J., LANZINO, G. (2020). CLINICAL, ANGIOGRAPHIC, AND TREATMENT CHARACTERISTICS OF CRANIAL DURAL ART ERIOVENOUS FISTULAS WITH PIAL ARTERIAL SUPPLY. JOURNAL OF NEUROINTERVENTIONAL SURGERY, 13(4), 331¿335. HTTPS://DOI.ORG/10.1136/NEURINTSURG-2020-016374 SUMMARY: THE PREVALENCE OF PIAL ARTERIAL SUPPLY TO CRANIAL DURAL ARTERIOVENOUS FISTULAS (DAVF) AND ITS IMPLICATION IN THE MANAGEMENT OF THESE FISTULAS IS NOT WELL CHARACTERIZED. WE PERFORMED A RETROSPECTIVE STUDY TO CHARACTERIZE PIAL ARTERIAL SUPPLY TO DURAL ARTERIOVENOUS FISTULAS AND THE IMPLICATIONS FOR TREATMENT. IDENTIFIED EVENTS: 2 PATIENTS HAD MAJOR COMPLICATIONS, RESULTING IN PERMANENT MORBIDITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687149 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other