BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 4743939 · Received May 1, 2015

    Report

    Report Number
    2029214-2015-00493
    Event Type
    Injury
    Date Received
    May 1, 2015
    Date of Event
    May 1, 2012
    Report Date
    April 2, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HTTP://WWW.NCBI.NLM.NIH.GOV/PMC/ARTICLES/PMC3467794/. THIS REPORT WAS CREATED TO CAPTURE THE COMPLICATIONS RELATED TO ONYX. THE ONYX WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. THE EVENT OCCURRED IN THE PATIENT POST PROCEDURE AND ITS CAUSE WAS UNKNOWN. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT REPORTED. INFORMATION RECEIVED FROM THE SAME ARTICLE AS MFRS: 2029214-2015-00492; 2029214-2015-00491. (B)(4). NOTE: THE PROCEDURE DESCRIBED IN THIS REPORT REQUIRED OFF-LABEL USE OF ONYX.

    Description of Event or Problem · 1

    CITATION: PETER ADAMCZYK, ET AL. RECURRENCE OF "CURED" DURAL ARTERIOVENOUS FISTULAS AFTER ONYX EMBOLIZATION. DEPARTMENT OF NEUROLOGICAL SURGERY, KECK SCHOOL OF MEDICINE, UNIVERSITY OF SOUTHERN CALIFORNIA, LOS ANGELES, CALIFORNIA. NEUROSURG FOCUS 32 (5):E12, 2012. THE FOLLOWING REPORT WAS RECEIVED BY MEDTRONIC (COVIDIEN) THROUGH REVIEW OF LITERATURE. A PATIENT WAS TREATED WITH ONYX 18 VIA A POSTERIOR PEDICLE OF THE RIGHT MIDDLE MENINGEAL ARTERY, RESULTING IN COMPLETE DURAL ARTERIOVENOUS FISTULA (DAVF) OCCLUSION WITH PERMEATION OF ONYX INTO THE DRAINING VEIN, AS CONFIRMED BY ANGIOGRAPHY AND SUBSEQUENT HEAD COMPUTERIZED TOMOGRAPHY (CT) SCANNING. THE PATIENT WAS EVENTUALLY ABLE TO RETURN TO HOME AND REMAINED CLINICALLY STABLE. HOWEVER, ADDITIONAL ANGIOGRAPHY PERFORMED 8 MONTHS LATER DEMONSTRATED RECANALIZATION OF THE (DAVF) FED BY BILATERAL BRANCHES OF THE MIDDLE MENINGEAL ARTERIES, SUPERFICIAL TEMPORAL ARTERIES, AND OCCIPITAL ARTERIES. PARTIAL THROMBOSIS WAS STILL PRESENT IN THE SUPERIOR SAGITTAL SINUS. STAGE II ONYX EMBOLIZATION WAS PERFORMED VIA THE ANTERIOR DIVISION OF THE RIGHT MIDDLE MENINGEAL ARTERY AS WELL AS THE POSTERIOR DIVISION OF THE LEFT MIDDLE MENINGEAL ARTERY. THIS RESULTED IN COMPLETE OBLITERATION OF THE FISTULA AND DRAINING VEIN ONCE AGAIN WITH COMPLETE PRESERVATION OF THE TRANSVERSE SINUS. THE PATIENT HAS HAD NO FURTHER SYMPTOMS AND IS AWAITING SURVEILLANCE ANGIOGRAPHIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288614 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-7100-060

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention