BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 24889402 · Received April 15, 2026

    Report

    Report Number
    2029214-2026-00681
    Event Type
    Injury
    Date Received
    April 15, 2026
    Date of Event
    April 6, 2026
    Report Date
    May 20, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    UDI-DI
    00847536006102
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR TRANS-ARTERIAL ENDOVASCULAR EMBOLIZATION FOR POSTERIOR CEREBRAL ARTERY (PCA) AVM USING ONYX. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH UNKNOWN DIAMETER.  IT WAS REPORTED THAT DURING TREATMENT OF A PCA AVM, A SOFIA 6F 125 CM INTERMEDIATE CATHETER WAS USED TO DELIVER AN APOLLO MICROCATHETER FOR ONYX EMBOLIZATION OF THE TARGET LESION. AFTER EMBOLIZATION OF THE MAIN FEEDING ROUTE, THE APOLLO MICROCATHETER WAS REMOVED. SUBSEQUENT ANGIOGRAPHY PERFORMED VIA THE INTERMEDIATE CATHETER REVEALED RESIDUAL ONYX MATERIAL WITHIN A SEGMENT OF THE VERTEBRAL ARTERY (VA), SPECIFICALLY IN THE HORIZONTAL SEGMENT. THE RESIDUAL ONYX WAS LATER OBSERVED TO MIGRATE DISTALLY AND BECOME LODGED IN THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA). A STENT WAS DEPLOYED TO SECURE THE RESIDUAL MATERIAL AGAINST THE VESSEL WALL. POST-PROCEDURE, THE PATIENT REGAINED CONSCIOUSNESS. THE PATIENT REPORTED MILD DISCOMFORT DURING MOVEMENT. NO ADDITIONAL COMPLICATIONS HAVE BEEN REPORTED AT THIS TIME. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.   ANCILLARY DEVICES INCLUDE AN ONYX 18 105-7000-060 (B)(4) LIQUID EMBOLIC, MDT X-PEDION 10 103-0605-200 (B)(4) GUIDEWIRE, STRYKER INFINITY GUIDE CATHETER, TERUMO SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603771 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 105-7000-060 D071887 00847536006102

    Patients

    Seq Age Sex Outcome Treatment
    1