BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6458050 · Received April 4, 2017

    Report

    Report Number
    2029214-2017-00363
    Event Type
    Injury
    Date Received
    April 4, 2017
    Date of Event
    February 27, 2006
    Report Date
    March 13, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BRAIN AVM EMBOLIZATION WITH ONYX. W.J.VAN ROOIJ, M. SLUZEWSKI, G. N. BEUTE ET. AL. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT. BASED ON THE REPORTED THE EVENT OCCURRED IN THE PATIENT POST PROCEDURE AND ITS CAUSE WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE AUTHOR OF THIS ARTICLE REGARDING THIS CASE. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MDRS RELATED TO THIS ARTICLE: 2029214-2008-00257 2029214-2017-00359 2029214-2017-00360 2029214-2017-00361 2029214-2017-00362 2029214-2017-00363 2029214-2017-00364 2029214-2017-00365 2029214-2017-00366 2029214-2017-00367 2029214-2017-00368.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW THAT THE DURING EMBOLIZATION PROCEDURE, ONYX REFLUX INTO AN M2 BRANCH THAT RESULTING IN PARTIAL OCCLUSION OF THE BRANCH. AFTER EMBOLIZATION, THE PATIENT EXPERIENCED DYSPHASIA AND AN MRI SHOWED A SMALL INFARCTION. SIX WEEKS LATER THE DYSPHASIA HAD RESOLVED, AND THE AVM REMNANT WAS TREATED WITH RADIO SURGERY THAT RESULT IN COMPLETE OBLITERATION 2 YEARS LATER. IT WAS REPORTED THAT PATIENT WITH A 3.5 CM RIGHT TEMPORAL AVM FED BY THE ANTERIOR TEMPORAL ARTERY (SPETZLER AND MARTIN GRADE II) WAS EMBOLIZED WITH ONYX. BETWEEN MAY 2000 AND DECEMBER 2005, 44 PATIENT WITH BRAIN AVMS WERE EMBOLIZED WITH ONYX. THERE WERE 18 WOMEN AND 26 MEN WITH A MEAN AGE OF 42.4 YEARS (MEDIAN 44, RANGE 14-71 YEARS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240093 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK-NV-ONYX NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention