BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 22592362 · Received July 24, 2025

    Report

    Report Number
    2029214-2025-01694
    Event Type
    Injury
    Date Received
    July 24, 2025
    Date of Event
    February 6, 2025
    Report Date
    July 24, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2: PATIENT AGE IS THE AVERAGE OF COHORT OF PATIENTS. A3: THE COHORT OF PATIENTS WAS MAJORITY MALE. SEE ATTACHMENTS FOR LITERATURE ARTICLE. 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

    ZHANG, G., PANG, M., DUAN, G., LI, Z., CHEN, R., SHANG, C., ZHANG, Y., HUANG, Q., XU, Y., LI, Q., & LIU, J.; ACTA NEUROCHIRURGICA; 2025; 167:51; TRANSARTERIAL EMBOLIZATION OF ANTERIOR CRANIAL FOSSA DURAL ARTERIOVENOUS FSTULAS AS A FRST-LINE APPROACH: A RETROSPECTIVE SINGLE-CENTER STUDY; DOI10.1007/S00701-025-06460-4 LITERATURE WAS REVIEWED REGARDING: THE CLINICAL AND ANGIOGRAPHIC OUTCOMES OF TRANSARTERIAL EMBOLIZATION (TAE) AS A FIRST-LINE TREATMENT FOR ANTERIOR CRANIAL FOSSA (ACF) DURAL ARTERIOVENOUS FISTULAS (DAVFS) OVER A TWENTY-YEAR PERIOD.  THE TIME FRAME OF THIS STUDY WAS: FROM MARCH 2001 TO SEPTEMBER 2021.  MULTIPLE MANUFACTURERS¿ DEVICES WERE USED IN THE STUDY POPULATION.  THE FOLLOWING MEDTRONIC DEVICES WERE USED: ONYX-18, AND ONYX-34. NO DEATHS WERE REPORTED. AMONG PATIENT ADVERSE EVENTS INCLUDED:   PARTIAL EMBOLIZATION (14.8%, 8/54), ONE PATIENT WAS REFERRED FOR SURGERY, WHILE THE REST WERE MANAGED CONSERVATIVELY WITH VIGILANT O BSERVATION. INTRA OPERATIVE COMPLICATIONS IN 3.7% (2/54) OF PATIENTS: RETINAL ISCHEMIA AFTER TAE.  WHEN THE PATIENT WAS DISCHARGED, HE COULD NOT SEE ANYTHING WITHIN 1 M. AT THE RECENT FOLLOW-UP PERFORMED BY TELEPHONE (36 MONTHS AFTER THE EMBOLIZATION), THE VISION IN HIS RIGHT EYE ONLY RETURNED TO COUNTING FINGERS WITHIN 50 CM. SUDDEN ONSET MILD HEADACHE DUE TO ACUTE INTRAPARENCHYMAL HEMORRHAGE WITH AN ASSOCIATED ACF DAVF, A TRANSARTERIAL ATTEMPT VIA OPHTHALMIC ARTERY (OA) COMPLICATED BY SUBARACHNOID HEMORRHAGE DUE TO INTRAOPERATIVE PERFORATION. SURGICAL INTERRUPTION OF THE SHUNT WAS PERFORMED IMMEDIATELY. ALTHOUGH THE HEADACHE WAS RELATIVELY SEVERE AND PERSISTENT ON THE FIRST POSTOPERATIVE DAY, IT GRADUALLY DISAPPEARED ON THE FIFTH POSTOPERATIVE DAY, AND NO ANALOGOUS SYMPTOM ONSET WAS OBSERVED DURING FOLLOW-UP. IMMEDIATE CLINICAL RESULTS: NO CHANGE IN 75.9% (41/54) OF PATIENTS. IMPROVEMENT IN 20.4% (11/54). WORSENING IN 3.7% (2/54).  FOLLOW-UP OUTCOMES: 83.3% (35/42) OF PATIENTS ASYMPTOMATIC. 14.3% (6/42) EXPERIENCED SYMPTOM IMPROVEMENT. 2.4% (1/42) REPORTED WORSENING SYMPTOMS DUE TO RETINAL ISCHEMIA FOLLOWING TAE. MEDIAN DSA FOLLOW-UP PERIOD: 6.7 MONTHS, WITH COMPLETE OCCLUSION ACHIEVED IN 80.6% (25/31) OF PATIENTS.  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2060856 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 105-7100-080 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention