BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 12773983 · Received November 8, 2021

    Report

    Report Number
    2029214-2021-01424
    Event Type
    Injury
    Date Received
    November 8, 2021
    Date of Event
    June 1, 2021
    Report Date
    November 8, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED PATIENT AGE (59 YEARS) IS REPRESENTATIVE OF THE MEAN AGE OF ALL PATIENTS INCLUDED IN THE STUDY, NOT NECESSARILY OF THIS PATIENT. REPORTED PATIENT SEX (MALE) IS REPRESENTATIVE OF THE MAJORITY OF PATIENTS INCLUDED IN THIS STUDY, NOT NECESSARILY OF THIS PATIENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MAYERCIK, V. A., SUSSMAN, E. S., PULLI, B., DODD, R. L., DO, H. M., TELISCHAK, N. A., MARKS, M. P., STEINBERG, G. K., CHANG, S. D., <(>&<)> HEIT, J. J. (2021). EFFICACY AND SAFETY OF EMBOLIZATION OF DURAL ARTERIOVENOUS FISTULAS VIA THE OPHTHALMIC ARTERY. INTERVENTIONAL NEURORADIOLOGY, 27(3), 444¿450. HTTPS://DOI.ORG/10.1177/1591019920969270 ABSTRACT INTRODUCTION: DURAL ARTERIOVENOUS FISTULAE (DAVF) ARE VASCULAR LESIONS WITH ARTERIOVENOUS SHUNTING THAT MAY BE TREATED WITH SURGICAL OBLITERATION OR ENDOVASCULAR EMBOLIZATION. SOME DAVF, SUCH AS ANTERIOR CRANIAL FOSSA DAVF (AC-DAVF) DERIVE THEIR ARTERIAL SUPPLY FROM OPHTHALMIC ARTERY BRANCHES IN NEARLY ALL CASES, AND TRANS-ARTERIAL EMBOLIZATION CARRIES A RISK OF VISION LOSS. WE DETERMINED THE EFFICACY AND SAFETY OF TRANS-OPHTHALMIC ARTERY EMBOLIZATION OF DAVF. MATERIALS AND METHODS: WE PERFORMED A RETROSPECTIVE COHORT STUDY OF ALL PATIENTS WITH DAVF TREATED BY TRANS-OPHTHALMIC ARTERY EMBOLIZATION FROM 2012 TO 2020. PRIMARY OUTCOME WAS ANGIOGRAPHIC CURE OF THE DAVF. SECONDARY OUTCOMES INCLUDED VISION LOSS, VISUAL IMPAIRMENT, ORBITAL CRANIAL NERVE INJURY, STROKE, MODIFIED RANKIN SCALE AT 90-DAYS, AND MORTALITY. RESULTS: 12 PATIENTS MET INCLUSION CRITERIA (9 MALES; 3 FEMALES). 10 PATIENTS HAD AC-DAVF. PATIENT AGE WAS 59.7 +/- 9.5 (MEAN) YEARS. PATIENTS PRESENTED WITH INTRACRANIAL HEMORRHAGE (4 PATIENTS), HEADACHE (4 PATIENTS), AMAUROSIS FUGAX (1 PATIENTS), OR WERE INCIDENTALLY DISCOVERED (2 PATIENTS). DAVF COGNARD GRADES WERE: II (1 PATIENT), III (6 PATIENTS), AND IV (5 PATIENTS). DAVF WERE EMBOLIZED WITH ONYX (10 PATIENTS), NBCA GLUE (1 PATIENT), AND A COMBINATION OF COILS AND ONYX (1 PATIENT). DAVF CURE WAS ACHIEVED IN 11 PATIENTS (92%). NO PATIENTS EXPERIENCED VISION LOSS, DEATH, OR PERMANENT DISABILITY. ONE PATIENT EXPERIENCED A MINOR COMPLICATION OF BLURRY VISION ATTRIBUTED TO POSTERIOR ISCHEMIC OPTIC NEUROPATHY. 90-DAY MRS WAS 0 (10 PATIENTS) AND 1 (2 PATIENTS). CONCLUSIONS: TRANS-OPHTHALMIC ARTERY EMBOLIZATION IS AN EFFECTIVE AND SAFE TREATMENT FOR DAVF. MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND THAT NO DEVICE MALFUNCTIONS OR INTEROPERATIVE ISSUES WERE REPORTED. 1 PATIENT EXPERIENCED BLURRY VISION THOUGHT TO BE DUE TO POSTERIOR ISCHEMIC OPTIC NEUROPATHY (PION). IT WAS NOTED IN THE ARTICLE THAT THE AUTHORS/RESEARCHERS BELIEVED THAT PION IN THIS CASE WAS NOT DUE TO THE ONYX EMBOLIZATION BUT WAS PROCEDURE RELATED WITH A CAUSAL RELATIONSHIP TO THE MICROCATHETER RATHER THAN THE ONYX AS THE ONYX EMBOLIZATION WAS PERFORMED DISTAL TO THE EXPECTED BLOOD SUPPLY TO THE OPTIC NERVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666308 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other