BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 11975329 · Received June 10, 2021

    Report

    Report Number
    2029214-2021-00712
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    October 1, 2020
    Report Date
    June 10, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CAI H, CHEN L, ZHANG N, TANG W, YANG F, LI Z. LONG-TERM FOLLOW-UP OF TRANSARTERIAL BALLOON-ASSISTED ONYX EMBOLIZATION FOR ENDOVASCULAR TREATMENT OF DURAL ARTERIOVENOUS FISTULAS: A SINGLE-INSTITUTION CASE SERIES AND LITERATURE REVIEW. CLIN NEUROL NEUROSURG. 2020 DE C;199:106256. DOI: 10.1016/J.CLINEURO.2020.106256. EPUB 2020 OCT 1. PMID: 33069089. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CAI H, CHEN L, ZHANG N, TANG W, YANG F, LI Z. LONG-TERM FOLLOW-UP OF TRANSARTERIAL BALLOON-ASSISTED ONYX EMBOLIZATION FOR ENDOVASCULAR TREATMENT OF DURAL ARTERIOVENOUS FISTULAS: A SINGLE-INSTITUTION CASE SERIES AND LITERATURE REVIEW. CLIN NEUROL NEUROSURG. 2020 DE C;199:106256. DOI: 10.1016/J.CLINEURO.2020.106256. EPUB 2020 OCT 1. PMID: 33069089. MEDTRONIC LITERATURE REVIEW FOUND REPORTED OF PATIENT COMPLICATIONS IN ASSOCIATION WITH ONYX INJECTION. THE PURPOSE OF THIS ARTICLE WAS TO INVESTIGATE THE LONG-TERM EFFICACY AND SAFETY OF TRANSARTERIAL BALLOONASSISTED ONYX EMBOLIZATION IN THE TREATMENT OF DURAL ARTERIOVENOUS FISTULAS (DAVFS). THE AUTHORS REVIEWED 14 CASES OF PATIENTS TREATED FOR DAVFS USING BALLOON-ASSISTED ONYX INJECTION VIA A SINGLE FEEDING ARTERY. OF THE 14 PATIENTS, THE AVERAGE AGE WAS 48 YEARS, 9 WERE FEMALE AND 5 WERE MALE. CLINICAL PRESENTATION INCLUDED INTRACEREBRAL HEMORRHAGE (N = 2), TINNITUS (N = 5), CONJUNCTIVAL CONGESTION (N = 4), HEADACHE (N = 2), AND HEMIPLEGIA (N = 1). THE DAVFS WERE IN THE SIGMOID SINUS (N = 4), CAVERNOUS SINUS (N = 4), TRANSVERSE SINUS (N = 3), FORAMEN MAGNUM (N = 2), AND ANTERIOR CRANIAL FOSSA (N = 1). FOLLOW-UP POST-PROCEDURE WAS DONE FOR 114.57 ¿ 33.52 MONTHS. COMPLETE OCCLUSION WAS ACHIEVED IN 13 CASES AND PARTIAL OCCLUSION IN 1 CASE. AT THE FINAL FOLLOW-UP, ALL PATIENTS WERE FUNCTIONALLY INDEPENDENT (MODIFIED RANKIN SCALE SCORE OF 02), WITH NO RECURRENCE. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE ECHELON MICROCATHETER OR ONYX 18 LIQUID EMBOLIC. THE MICROCATHETER WAS SUCCESSFULLY REMOVED IN ALL CASES. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: ONE PATIENT DEVELOPED ACUTE MYOCARDIAL INFARCTION DURING FOLLOW-UP AND RECEIVED STENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874030 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention