BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO

    MDR report key: 24758164 · Received April 1, 2026

    Report

    Report Number
    2029214-2026-00589
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    September 13, 2025
    Report Date
    April 1, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    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.

    Description of Event or Problem · 0

    WANG J, WANG T, WANG C, HU F. MECHANICAL REMOVAL OF MIGRATED ONYX18 DUE TO RUPTURE OF A DETACHABLE-TIP MICROCATHETER DURING ARTERIOVENOUS MALFORMATION EMBOLIZATION. NEUROL INDIA 2025;73:1058-60. MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND A CASE REVIEW OF A PATIENT WHO WAS UNDERGOING A PROCEDURE FOR EMBOLIZATION OF A LEFT FRONTAL ARTERIOVENOUS MALFORMATION (AVM). AN APOLLO MICROCATHETER WAS USED FOR DELIVERY OF ONYX 18 DURING THE PROCEDURE. AFTER INJECTING APPROXIMATELY 1 ML OF ONYX18 OVER 5 MINUTES WITH NO REFLUX, IT WAS NOTED THAT ONYX WAS OBSERVED EXITING FROM A PERFORATED POINT THE APOLLO CATHETER. ACCIDENTAL MIGRATION OF ONYX18 INTO THE MIDDLE CEREBRAL ARTERY (MCA) AND ANTERIOR CEREBRAL ARTERY (ACA) DUE TO A RUPTURED MICROCATHETER. THE ONYX MIGRATION WAS SUCCESSFULLY TREATED USING AN ASPIRATION CATHETER, A REBAR 27 MICROCATHETER, AND A SOLITAIRE AB STENT. THE ARTICLE CONCLUDED POTENTIAL CAUSES FOR MICROCATHETER RUPTURE INCLUDE SUBSTANDARD MICROCATHETER QUALITY, PROLONGED INJECTION INTERVALS, INADEQUATE ONYX MIXING BEFORE INJECTION, AND EXTENDED SYRINGE RETENTION IN A FIXED POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816074 APOLLO AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-APOLLO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female