BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX AVM

    MDR report key: 23735532 · Received December 5, 2025

    Report

    Report Number
    2029214-2025-02549
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 2, 2025
    Report Date
    December 16, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    UDI-DI
    00847536006102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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.

    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

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT ASIDE FROM THE ABNORMAL VISUALIZATION OF ONYX, THERE WERE NO OTHER ISSUES WITH THE PRODUCT. NO ISSUES WITH THE GUIDEWIRE (MODEL 103-0608, LOT NO. D050584) AND NAVIEN CATHETER. THE ANATOMICAL LOCATION OF THE APOLLO TIP WAS THE DISTAL END OF THE MICROCATHETER.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT DURING ARTERIOVENOUS MALFORMATION (AVM) EMBOLIZATION, AFTER OPENING THE APOLLO MICROCATHETER AND HEPARINIZING IT. THE DISTAL BRANCH OF THE OPHTHALMIC ARTERY WAS REACHED UNDER THE GUIDANCE OF A MICRO GUIDEWIRE. THE MICROCATHETER WAS FLUSHED WITH DMSO, AND A LIQUID EMBOLIC WAS INJECTED. ABNORMAL VISUALIZATION OF THE LIQUID EMBOLIC WAS OBSERVED WITHIN THE INTERMEDIATE CATHETER; THEREFORE, BOTH THE INTERMEDIATE CATHETER AND MICROCATHETER WERE REMOVED. IN VITRO OBSERVATION REVEALED THAT THE MICROCATHETER HAD A LIQUID EMBOLIC LEAKING OUT WITHIN THE INTERMEDIATE CATHETER, AND IT WAS FOUND THAT THE MICROCATHETER LEAKED LIQUID EMBOLIC MID CATHETER. THEREFORE, THE INTERMEDIATE CATHETER AND ANOTHER APOLLO MICROCATHETER  WERE REPLACED TO CONTINUE THE SURGICAL PROCEDURE.  NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING MIDDLE MENINGEAL ARTERY LIQUID EMBOLIZATION SURGERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE, AND THE PATIENT HAS A HISTORY OF HYPERTENSION. FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 7 MM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE MICROCATHETER WAS INSPECTED OR TESTED PRIOR TO USE AND THE LEAK WAS OBSERVED DURING USE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE LEAK/CATHETER RUPTURE WAS NOT DETERMINED. UPON INJECTION OF THE LIQUID EMBOLIC AGENT INTO THE APOLLO, THERE WAS NO RESISTANCE. THERE WAS CONTINUOUS INJECTION OF THE LIQUID EMBOLIC AGENT. THE INJECTION RATE WAS FOLLOWED AS INDICATED IN THE IFU. THE LIQUID EMBOLIC AGENT DID NOT GET EMBEDDED IN AN UNINTENDED LOCATION. THIS EVENT DID NOT REQUIRE MEDICAL INTERVENTION. THE PATIENT IS TEMPORARILY NORMAL. THERE WAS KINK/DAMAGE ON THE DISTAL END OF THE APOLLO. GUIDEWIRE: MODEL 103-0608, LOT NO. D050584. LIQUID EMBOLIZATION SYSTEM: MODEL 105-7000-060, LOT NUMBER B768221. INTERMEDIATE CATHETER: NAVIEN, MODEL RFX058-115-08.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2877880 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 105-7000-060 B768221 00847536006102

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male