BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX AVM

    MDR report key: 7366604 · Received March 23, 2018

    Report

    Report Number
    2029214-2018-00225
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    August 28, 2014
    Report Date
    March 23, 2018
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PURI, A. S., KÜHN, A. L., HOU, S. Y., <(>&<)> WAKHLOO, A. K. (2014). USE OF INTERMEDIATE GUIDE CATHETERS AS AN ADJUNCT IN EXTRACRANIAL EMBOLIZATION TO AVOID ONYX REFLUX INTO THE ANASTOMOTIC VASCULATURE. INTERVENTIONAL NEURORADIOLOGY, 20(4), 424-427. DOI.ORG/10.152 74/INR-2014-10040 THE ONYX LIQUID EMBOLIC WAS PLACED IN THE PATIENT AND WILL NOT BE RETURNED FOR EVALUATION. THE ONYX WAS NOT RETURNED; THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED FROM THE PROVIDED INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF UNCONTROLLED ONYX REFLUX DURING A PROCEDURE. THE PATIENT PRESENTED WITH A SYMPTOMATIC MEDIAL TENTORIAL DURAL ARTERIOVENOUS FISTULA (DAVF). THE DAVF WAS FED BY THE MENINGEAL BRANCH OF THE OCCIPITAL ARTERY(OA) AND THE MENINGOHYPOPHYSEAL TRUNK OF THE IPSILATERAL CAROTID. THE TREATMENT PLAN WAS TO EMBOLIZE THE DAVF WITH ONYX 34. DURING THE EMBOLIZATION PROCEDURE, A 6F SHUTTLE WAS PLACED INTO THE COMMON CAROTID ARTERY, THROUGH WHICH AN 058 INTERMEDIATE GUIDE CATHETER WAS PLACED INTO THE OA. A MICROCATHETER WAS ADVANCED AS CLOSE AS POSSIBLE TO THE VENOUS ECTASIA. AFTER PREPPING WITH DMSO, ONYX 34 WAS SLOWLY INFUSED BY THE ¿PLUG AND PUSH¿ TECHNIQUE. HOWEVER, THE ONYX REFLUX REACHED THE MAIN OA BEFORE THE ENTIRE DAVF COULD BE EMBOLIZED. TO PREVENT ONYX FROM REFLUXING INTO THE OA, THE GUIDE CATHETER WAS ADVANCED INTO THE OSTIUM OF THE MENINGEAL BRANCH OF THE OA. ONYX INJECTION WAS CONTINUED. COMPLETE EMBOLIZATION OF THE DAVF WAS PERFORMED USING THE LUMEN OF THE GUIDE CATHETER TO ACCEPT AGGRESSIVE ONYX REFLUX. IMAGING CONFIRMED THAT ONYX REFLUXED INTO THE GUIDE CATHETER RATHER THAN INTO THE OA. COMPLETE CURE OF THE DAVF WAS OBTAINED WITH ONYX CAST FILLING THE ENTIRE VENOUS POUCH. AT THE END OF THE PROCEDURE, THE MICROCATHETER AND THE GUIDE CATHETER WERE REMOVED UNDER CONSTANT ASPIRATION. NO INTRAPROCEDURAL COMPLICATIONS WERE NOTED. POST-EMBOLIZATION ANGIOGRAMS DEMONSTRATED NO REFLUX OF ONYX INTO THE POSTERIOR CERVICAL BRANCH OF THE OA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209514 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-7100-080

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR