BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX

    MDR report key: 22566020 · Received July 22, 2025

    Report

    Report Number
    2029214-2025-01658
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    May 19, 2025
    Report Date
    July 22, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2. REPORTED PATIENT AGE (60 YEARS) IS THE MEAN AGE FROM ALL PATIENTS IN THE STUDY GROUP. A3A. REPORTED PATIENT SEX IS REPRESENTATIVE OF THE MAJORITY OF PATIENTS (20/30) IN THE STUDY GROUP. B3. REPORTED DATE OF EVENT IS THE DATE OF THE ARTICLE'S ELECTRONIC PUBLICATION. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    GOAPPER, M., VAN DOKKUM, L. E. H., COSTALAT, V., RISI, G., CORTI, L., PORTALIER, O., LONJON, N., LE BARS, E., DUCROS, A., CAGNAZZO, F. (2025). THE IMPACT OF CSF VENOUS FISTULA EMBOLIZATION ON PATIENT¿S QUALITY OF LIFE, A LONGITUDINAL CLINICAL-RADIOLOGICAL EXPLORATION. THE JOURNAL OF HEADACHE AND PAIN, 26(1), 120. HTTPS://DOI.ORG/10.1186/S10194-025-02056-6. MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND A STUDY OF 30 PATIENTS SYMPTOMATIC SPONTANEOUS INTRACRANIAL HYPOTENSION (SIH AND CEREBROSPINAL FLUID-VENOUS FISTULAS (CSFVF) WHO UNDERWENT ONYX EMBOLIZATION. THE STUDY PARTICULARLY FOCUSED ON THE IMPACT OF TREATMENT ON PATIENTS' QUALITY OF LIFE (QOL). THE ARTICLE SPECIFIED TREATMENT WAS SUCCESSFUL IN ALL CASES AND THERE WAS NO TREATMENT-RELATED MORBIDITY. MULTIPLE DEVICES WERE USED IN THE TREATMENT PROCEDURES. MEDTRONIC DEVICES USED INCLUDE 7F RIST GUIDE CATHETERS AND ONYX 18 LIQUID EMBOLIZATION SYSTEM. THERE WAS ONE CASE OF ONYX MIGRATION INTO THE AZYGOS VEIN. NO ADDITIONAL INTERVENTION OR ASSOCIATE PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. SEVEN PATIENTS DEVELOPED TRANSIENT LOCAL BACK PAIN AT THE SITE OF ONYX INJECTION. TWO CASES OF ASYMPTOMATIC EPIDURAL PLEXUS PERFORATION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766914 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female