BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 22612937 · Received July 25, 2025

    Report

    Report Number
    2029214-2025-01699
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    April 8, 2025
    Report Date
    July 25, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: YU, J.. EMBOLIZATION OF BILATERAL CAVERNOUS SINUS DURAL ARTERIOVENOUS FISTULAS VIA THE ASCENDING PHARYNGEAL ARTERY USING THE ¿PRESSURE COOKER¿ TECHNIQUE: A CASE REPORT. INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS 130 (2025) 111272 2025. DOI: 10.1016/J. IJSCR.2025.111272 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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

    LITERATURE WAS REVIEWED REGARDING EMBOLIZATION OF BILATERAL CAVERNOUS SINUS DURAL ARTERIOVENOUS FISTULAS VIA THE ASCENDING PHARYNGEAL ARTERY USING THE ¿PRESSURE COOKER¿ TECHNIQUE: A CASE REPORT THE FOLLOWING MEDTRONIC DEVICES WERE USED: ONYX-18 LIQUID EMBOLIC, ECHELON-10 MICROCATHETER, AND MARATHON MICROCATHETER. AMONG ALL PATIENT'S ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: POSTOPERATIVE 2ND DAY COMPUTED TOMOGRAPHY REVEALED THAT THE ONYX AGENT HAD MIGRATED INTO THE CRANIAL VESSELS. POSTOPERATIVE 3RD DAY MR IMAGE REVEALED AN ASYMPTOMATIC ACUTE INFARCTION OF THE RIGHT HEAD OF THE CAUDATE NUCLEUS. THE PATIENT AWOKE POSTOPERATIVELY AND PATIENT SUFFERED MINOR NUMBNESS AND PARALYSIS ON THE LEFT SIDE OF HER FACE DUE TO INJURY TO THE CRANIAL NERVE BRANCHES OF THE MMA AND AMA. ONE MONTH LATER, THE PATIENT RECOVERED WELL, NUMBNESS AND PARALYSIS OF THE FACE HAD DISAPPEARED. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2267579 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other