BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 9179383 · Received October 11, 2019

    Report

    Report Number
    2029214-2019-01019
    Event Type
    Injury
    Date Received
    October 11, 2019
    Date of Event
    June 14, 2017
    Report Date
    October 11, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. SINCE THE DEVICE WAS NOT RETURNED, WE ARE UNABLE TO PERFORM FURTHER ROOT CAUSE ANALYSIS. ALL DEVICES ARE 100% TESTED AND ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. NEUROLOGICAL DETERIORATION ARE KNOWN INHERENT RISK OF ENDOVASCULAR PROCEDURE AND ARE DOCUMENTED IN OUR DEVICE¿S INSTRUCTION FOR USE (IFU). BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE AND PATIENT CONDITION RELATED EVENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VWT CHAN, SSM LO, DPH WONG, KF FOK, KW TANG, ¿TRANSVENOUS EMBOLISATION OF DURAL ARTERIOVENOUS FISTULAS WITH COMBINATION OF GUGLIELMI DETACHABLE COILS AND ONYX: PRELIMINARY EXPERIENCE AND EVALUATION OF THE CLINICAL OUTCOMES¿ HTTPS://DOI.ORG/10.12809/HKJR1916900. MEDTRONIC RECEIVED THE FOLLOWING EVENTS THROUGH LITERATURE REVIEW OF ¿TRANSVENOUS EMBOLISATION OF DURAL ARTERIOVENOUS FISTULAS WITH COMBINATION OF GUGLIELMI DETACHABLE COILS AND ONYX: PRELIMINARY EXPERIENCE AND EVALUATION OF THE CLINICAL OUTCOMES¿. FIVE CONSECUTIVE PATIENTS (THREE MEN AND TWO WOMEN; MEAN AGE 37.2 YEARS, RANGE 23-60 YEARS) WERE RECRUITED. ALL DAVF SHUNTS WERE LOCATED ALONG THE VENOUS SINUS WALL OR TENTORIAL BRIDGING VEIN WITH NON-DIRECT AND NON-EXCLUSIVE LEPTOMENINGEAL VENOUS REFLUX AND RETAINED VENOUS SINUS ANTEGRADE FLOW (COGNARD CLASSIFICATION TYPE IIB). TWO OF THESE PATIENTS RECEIVED PRIOR EMBOLIZATION TREATMENT (ONE WITH TRANSARTERIAL ONYX, ONE WITH TRANSARTERIAL NBCA) BUT THEY PRESENTED WITH PERSISTENT SYMPTOMS RELATED TO RESIDUAL DAVFS. THE MAIN PRESENTING SYMPTOMS INCLUDED: HEADACHE, SEIZURE, VISUAL SYMPTOMS, ALTERED MENTAL STATUS DUE TO UNDERLYING INTRAVENTRICULAR HEMORRHAGE, AND PULSATILE SCALP MASS. SUCCESSFUL EMBOLIZATION OF THE DAVF VENOUS OUTFLOW AND INVOLVED VENOUS SINUSES WAS ACHIEVED IN ALL FIVE CASES. THERE WAS NO NON-TARGET EMBOLIZATION. AMONG THE FIVE CASES, COMPLETE OBLITERATION (TOTAL DISAPPEARANCE OF ARTERIOVENOUS SHUNTING) OF THE DAVFS WERE ACHIEVED IN TWO (40%) CASES, AND NEAR TOTAL OCCLUSION (SIGNIFICANT REDUCTION OF ARTERIOVENOUS SHUNTING WITH A SMALL RESIDUAL SHUNT) IN ONE CASE, IN SINGLE-STAGE EMBOLIZATION PROCEDURE. IN THE OTHER TWO CASES, NEAR-TOTAL OCCLUSION OF THE DAVF WAS ACHIEVED AFTER TWO SEPARATE SESSIONS OF EMBOLIZATION WITH SLOW FLOW RESIDUAL ARTERIOVENOUS SHUNT (FIGURES 1 AND 2). ALL PATIENTS REPORTED SYMPTOM ALLEVIATION AFTER THE PROCEDURE(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974937 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other