BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 21608348 · Received March 14, 2025

    Report

    Report Number
    2029214-2025-00680
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    September 13, 2024
    Report Date
    March 14, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: LUO, C.-B., LEE, C.-H., LO, H.-Y., CHANG, F.-C., LIN, C.-J. (2024). ONYX AS AN ADJUNCTIVE EMBOLIC MATERIAL FOR TRANSVENOUS EMBOLIZATION OF CAVERNOUS SINUS DURAL ARTERIOVENOUS FISTULA AFTER COILING. JOURNAL OF THE CHINESE MEDICAL ASSOCIATION. HTTP S://DOI.ORG/10.1097/JCMA.0000000000001196 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. PATIENT AGE AND SEX ARE THE MEAN OF THE PATIENTS IN THE STUDY. 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

    LUO, C.-B., LEE, C.-H., LO, H.-Y., CHANG, F.-C., LIN, C.-J. (2024). ONYX AS AN ADJUNCTIVE EMBOLIC MATERIAL FOR TRANSVENOUS E MBOLIZATION OF CAVERNOUS SINUS DURAL ARTERIOVENOUS FISTULA AFTER COILING. JOURNAL OF THE CHINESE MEDICAL ASSOCIATION. HTTPS://DOI.ORG/10.1097/JCMA.0000000000001196 LITERATURE WAS REVIEWED REGARDING ONYX AS AN ADJUNCTIVE EMBOLIC MATERIAL FOR TRANSVENOUS EMBOLIZATION OF CAVERNOUS SINUS DURAL ARTERIOVENOUS FISTULA AFTER COILING. THE FOLLOWING MEDTRONIC DEVICES WERE USED: ONYX-34 AMONG ALL PATIENTS ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: ONE PATIENT (1.1%) EXPERIENCED HEMORRHAGIC COMPLICATIONS DURING TRANSVENOUS COIL AND ONYX EMBOLIZATION (TVCOE). PATIENT EXPERIENCED A POSTPROCEDURAL HEADACHE ATTRIBUTED TO A SMALL AMOUNT OF SUBARACHNOID HEMORRHAGE, BELIEVED TO BE CAUSED BY INJURY TO THE DURA FROM THE GUIDEWIRE/CATHETER SYSTEM DURING MANIPULATION. NEW-ONSET (N = 1) AND AGGRAVATED (N = 1) SIXTH CRANIAL NERVE PALSY (CNP) OCCURRED IN 2 (2.2%) CAVERNOUS SINUS DURAL ARTERIOVENOUS FISTULAS (CSDAVFS), WITH ALMOST COMPLETE REGRESSION DURING THE 6-MONTH CLINICAL FOLLOW-UP. CAVERNOUS SYMPTOMS WITH CNP OBSERVED IN 51 (56.7%) OF 90 PATIENTS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433690 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Other