BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 7034261 · Received November 15, 2017

    Report

    Report Number
    2029214-2017-01255
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    October 1, 2017
    Report Date
    November 15, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CAYLI E, OGUZ S, DINC H. MECHANICAL EXTRACTION OF A REFLUXED ONYX PIECE FROM THE SIGMOID SINUS USING A SOLITAIRE AB STENT FOR TREATING A DURAL ARTERIOVENOUS FISTULA: TECHNICAL REPORT. EURASIAN J MED 2017; 49: 224-5. DOI: 10.5152/EURASIANJMED.2017.17260 THE ONYX WAS USED IN THE EMBOLIZATION OF AN DAVF. THE ONYX WAS CONSUMED DURING THE PROCEDURE AND REMAINS IN THE PATIENT. PRODUCT ANALYSIS WILL NOT BE PERFORMED. THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED FROM THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF ONYX REFLUX INTO AN UNINTENDED VESSEL. THE ARTICLE STATES THAT A PATIENT PRESENTED WITH TINNITUS. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) REVEALED A LEFT SIGMOID SINUS DURAL ARTERIOVENOUS FISTULA (DAVF) PRIMARILY SUPPLIED BY THE LEFT MIDDLE MENINGEAL ARTERY AND POSTERIOR AURICULAR ARTERY. THE FISTULA WAS CLASSIFIED AS MERLAND-COGNARD TYPE II A+B. THEPATIENT UNDERWENT ONYX EMBOLIZATION OF THE DAVF. ONYX INJECTION WAS PERFORMED THROUGH THE POSTERIOR AURICULAR ARTERY. DURING THE INJECTION, THE ARTICLE STATES THAT A SMALL AMOUNT OF ONYX REFLUXED INTO THE LEFT SIGMOID SINUS. A STENT WAS USED TO RETRIEVE THE REFLUXED PIECE. POST-PROCEDURE, THE FISTULA WAS DOWNGRADED TO TYPE I.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812727 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention