BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 4841410 · Received June 12, 2015

    Report

    Report Number
    2029214-2015-00650
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    August 1, 2009
    Report Date
    May 14, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/19625907. THIS REPORT WAS CREATED TO CAPTURE THE SERIOUS INJURIES RELATED TO THE ONYX. THE ONYX WAS NOT RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE ONYX WAS DEFECTIVE OR A DEFECT OF THE ONYX DURING USE, BUT RATHER PROCEDURE RELATED AND POST PROCEDURE EVENTS AND THEIR CAUSES WERE UNKNOWN. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBERS WERE NOT REPORTED. NOTE: PER THE ONYX IFU (INSTRUCTION FOR USE): DO NOT ALLOW MORE THAN 1 CM OF ONYX TO REFLUX BACK OVER CATHETER TIP. EXCESSIVE ONYX REFLUX RESULT IN DIFFICULT CATHETER REMOVAL AND POTENTIAL ENTRAPMENT. (B)(4). INFORMATION RECEIVED FROM THE SAME ARTICLE AS MFR 2029214-2015-00651.

    Description of Event or Problem · 1

    CITATION: QUINGAI HUANG. USE OF ONYX IN THE MANAGEMENT OF TENTORIAL DURAL ARTERIOVENOUS FISTULE.NEUROSURGERY. 2009 AUG;65(2):287-92; DISCUSSION 292-3. DOI: 10.1227/01.NEU.0000348298.75128.D0. THE FOLLOWING REPORT WAS RECEIVED BY MEDTRONIC (COVIDIEN): THREE PATIENTS EXPERIENCED RE-BLEEDING WITHIN 1 MONTH OF ONSET. ONE PATIENT REQUIRED A SECOND ONYX EMBOLIZATION VIA THE LEFT (INTERNAL CAROTID ARTERY) ICA, DUE TO RESIDUAL FILLING OF THE FISTULA BEING REVEALED DURING A 9 MONTH FOLLOW ANGIOGRAPHY. THIS RESULTED IN ANGIOGRAPHIC CURE. ONE PATIENT HAD MICROCATHETER RETENTION. THE FEEDING ARTERIES IN THIS PATIENT INCLUDED THE RIGHT TENTORIAL ARTERY BRANCHES OF THE LEFT OCCIPITAL ARTERY AND THE ASCENDING PHARYNGEAL ARTERY AND THE LEFT SUPERIOR CEREBELLAR ARTERY. THE LENGTHENED, SMALL AND TORTUOUS PATHWAY FROM THE THREE FORMER FEEDING ARTERIES MADE MICROCATHETER CANNULATION DIFFICULT. THE CATHETER WAS EASILY POSITIONED THROUGH THE SUPERIOR CEREBELLAR ARTERY INTO THE FISTULA. ONYX 18 WAS INJECTED FOR 25 MINUTES, AND THE FISTULA WAS TOTALLY OCCLUDED. ONYX REFLUX WAS LONGER THE 2.5 CM, WHICH RESULTED IN RETENTION OF MICROCATHETER. THE PATIENT WAS GIVEN A DAILY DOSE OF 100 MG OF ASPIRIN ORALLY FOR 3 MONTHS. THE PATIENT RECOVERED WELL WITH NEUROLOGICAL INTACT. A TOTAL OF 16 PATIENTS PRESENTED WITH TENTORIAL DURAL FISTULAE. OF THESE, 14 PATIENTS WERE TREATED WITH TRANSARTERIAL EMBOLIZATION (13 MEN AND 1 WOMAN). THE PATIENTS AGES RANGED FROM 37-65 (MEAN AGE, 50 YEARS). ULTRAFLOW OR MARATHON MICROCATHETERS WERE USED IN THE PROCEDURES. IT IS UNKNOWN WHICH OF THE TWO WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385258 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R| S