BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 11733219 · Received April 27, 2021

    Report

    Report Number
    2029214-2021-00493
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    August 26, 2020
    Report Date
    April 27, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VOLKER MAUS, FINN DRESCHER, LUKAS GOERTZ, ANUSHE WEBER, WERNER WEBER, SEBASTIAN FISCHER. ENDOVASCULAR TREATMENT OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULAS: A GERMAN SINGLE-CENTER EXPERIENCE. CEREBROVASC DIS EXTRA 10 (2020). DOI: 10.1159/000509455 BACKGROUND AND PURPOSE: INTRACRANIAL DURAL ARTERIOVENOUS FISTULAS (DAVFS) ARE ABNORMAL SHUNTS BETWEEN DURAL ARTERIES AND DURAL VENOUS SINUS OR CORTICAL VEINS. WE REPORT OUR EXPERIENCE WITH ENDOVASCULAR THERAPY OF PRIMARY COMPLEX DAVFS USING MODERN EMBOLIC AGENTS. METHODS: THIS IS A RETROSPECTIVE ANALYSIS OF PATIENTS WITH DAVFS TREATED BETWEEN 2015 AND 2019. PATIENT DEMOGRAPHICS AND TECHNICAL ASPECTS INCLUDING THE USE OF EMBOLIC AGENT, ACCESS TO THE FISTULA, NUMBER OF TREATMENTS, OCCLUSION RATES, AND COMPLICATIONS WERE ADDRESSED. ANGIOGRAPHIC TREATMENT SUCCESS WAS DEFINED AS COMPLETE OCCLUSION (CO) OF THE DAVF. RESULTS: FIFTY PATIENTS WERE TREATED ENDOVASCULARLY. MEDIAN AGE WAS 61 YEARS AND 66% WERE MEN. THE MOST COMMON SYMPTOM WAS PULSATILE TINNITUS IN 17 PATIENTS (34%). THE MOST FREQUENT LOCATION OF THE DAVF WAS THE TRANSVERSE-SIGMOID SINUS (40%). THIRTY-SIX FISTULAS (72%) HAD CORTICAL VENOUS REFLUX. NONADHESIVE AND ADHESIVE LIQUID AGENTS WERE USED IN 92% AS A SINGLE MATERIAL OR IN COMBINATION. CO WAS ACHIEVED IN 48 PATIENTS (96%). IN 28 INDIVIDUALS (56%), ONLY 1 PROCEDURE WAS NECESSARY. NONADHESIVE LIQUID AGENTS WERE EXCLUSIVELY USED IN 14 PATIENTS (28%) WITH CO ATTAINED IN EVERY CASE. FOR CO OF TENTORIAL DAVFS, MULTIPLE SESSIONS WERE MORE OFTEN REQUIRED THAN AT THE OTHER LOCATIONS (55 VS. 14%, P = 0.0051). AMONG 93 PROCEDURES, THE OVERALL COMPLICATION RATE WAS 3%. THE PROCEDURE-RELATED MORTALITY RATE WAS 0%. CONCLUSION: EN DOVASCULAR TREATMENT OF INTRACRANIAL DAVFS IS FEASIBLE, SAFE, AND EFFECTIVE WITH HIGH RATES OF CO. IN MORE THAN HALF OF THE PATIENTS, THE DAVF WAS COMPLETELY OCCLUDED AFTER A SINGLE PROCEDURE. HOWEVER, IN TENTORIAL DAVFS, MULTIPLE SESSIONS WERE MORE OFTEN REQUIRED. REPORTED EVENTS - TWO PATIENTS UNDERWENT SUBSEQUENT SURGERY (DUE TO ANTERIOR CRANIAL FOSSA AND TENTORIAL DAVFS, RESPECTIVELY). IN 2 PATIENTS, FISTULA RECURRENCE OCCURRED DESPITE CO AFTER THE FIRST PROCEDURE; BOTH WERE TREATED SUCCESSFULLY IN A SECOND INTERVENTION. - AMONG 93 PROCEDURES, THE OVERALL COMPLICATION RATE WAS 3% (3 PROCEDURES) AND INCLUDED TEMPORARY CRANIAL NERVE PALSY (N = 1), ISCHEMIC BRAIN LESIONS DUE TO CARRYOVER OF EMBOLIC MATERIAL (N = 1), AND TEMPORARY ASYSTOLIA DURING DMSO INJECTION PRIOR TO EMBOLIZATION (N =1). NONE OF THE PATIENTS HAD PERMANENT DEFICITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629652 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R