BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 10813760 · Received November 9, 2020

    Report

    Report Number
    2029214-2020-01108
    Event Type
    Injury
    Date Received
    November 9, 2020
    Date of Event
    August 16, 2020
    Report Date
    November 9, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ABAUNZA-CAMACHO JF, VERGARA-GARCIA D, PEREZ F, ET AL. DIRECT TRANSCRANIAL COIL AND ONYX EMBOLIZATION OF A DURAL ARTERIOVENOUS FISTUL A: TECHNICAL NOTE AND BRIEF LITERATURE REVIEW. JOURNAL OF CLINICAL NEUROSCIENCE. 2020;80:232-237. MEDTRONIC RECEIVED LITERATURE ARTICLE PERTAINING TO A CASE OF A MAN WHO PRESENTED WITH INTRACRANIAL HYPERTENSION SECONDARY TO AHIGH-GRADE DAVF. PRIOR TO INTERVENTION THE PATIENT COMPLAINED OF FRONTOTEMPORAL OPPRESSIVE INTENSE HEADACHES AND VISUAL ABNORMALITIES DURING THE LAST 10 DAYS. THE PATIENT INITIALLY UNDERWENT LIQUID EMBOLIZATION OF THE RIGHT MIDDLE MENINGEAL, RIGHT OCCIPITAL, AND RIGHT POSTERIOR AURICULAR ARTERIES, THROUGH INTRAARTERIAL FEMORAL APPROACH. POST-EMBOLIZATION CEREBRAL ANGIOGRAPHY SHOWED OCCLUSION OF 80% OF THE SHUNT. THE LEFT FEMORAL VEIN WAS THEN CANNULATED TO INTENT A TRANSVENOUS COIL EMBOLIZATION OF THE RIGHT SIGMOID-TRANSVERSE SINUS JUNCTION. HOWEVER, IT WAS NOT POSSIBLE BECAUSE THE RIGHT TRANSVERSE SINUS AND THE FIRST PORTION OF THE RIGHT SIGMOID SINUS WERE ANATOMICALLY DISCONNECTED FROM THE LEFT TRANSVERSE SINUS AND THE REMAINING CAUDAL TWO-THIRDS OF THE RIGHT SIGMOID SINUS, RESPECTIVELY. ALSO, ACCESS THROUGH THE SUPERIOR PETROSAL SINUS WAS NOT ANATOMICALLY POSSIBLE. A DECISION WAS MADE TO OFFER EXPECTANT MANAGEMENT AND IMAGING FOLLOW-UP FOR THE RESIDUAL FISTULA. A FOLLOW-UP CEREBRAL ANGIOGRAPHY WAS PERFORMED ONE MONTH AFTER THE INITIAL EMBOLIZATION, SHOWING RECANALIZATION OF 30% OF THE LESION. FURTHERMORE, THE PATIENT COMPLAINED OF PROGRESSIVE DETERIORATION OF HIS VISUAL ACUITY. AS A RESULT A TRANSCRANIAL COIL EMBOLIZATION OF THE RIGHT SIGMOID-TRANSVERSE SINUS JUNCTION WAS PERFORMED. ONE MONTH AFTER THE SECOND EMBOLIZATION, THE PATIENT REPORTED COMPLETE RESOLUTION OF HIS VISUAL SYMPTOMS, AND A CEREBRAL ANGIOGRAPHY REVEALED NO RESIDUAL FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273739 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention