BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6458043 · Received April 4, 2017

    Report

    Report Number
    2029214-2017-00368
    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
    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 DEVICES WERE NOT RETURNED FOR EVALUATION; THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE EVENT CAUSES COULD NOT BE DETERMINED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE AUTHOR OF THIS ARTICLE REGARDING THIS CASE. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PER ONYX INSTRUCTION FOR USE: DO NOT ALLOW MORE THAN 1 CM OF ONYX¿ LES TO REFLUX BACK OVER CATHETER TIP. ANGIOARCHITECTURE, VASOSPASM, EXCESSIVE ONYX REFLUX, OR PROLONGED INJECTION TIME MAY RESULT IN DIFFICULT CATHETER REMOVAL AND CATHETER ENTRAPMENT. EXCESSIVE FORCE TO REMOVE AN ENTRAPPED CATHETER MAY CAUSE SERIOUS INTRACRANIAL HEMORRHAGE. THE LONG TERM EFFECTS OF AN ENTRAPPED CATHETER THAT IS LEFT IN A PATIENT IS UNKNOWN, BUT COULD POTENTIALLY INCLUDE CLOT FORMATION, INFECTION OR CATHETER MIGRATION. MDRS RELATED TO THIS ARTICLE: 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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW THAT DURING EMBOLIZATION PROCEDURE WITH ONYX, THE CATHETER GLUED IN THE ANTERIOR VENOUS MALFORMATION (AVM) IN 2 PATIENTS. MICROCATHETER WAS CUT OFF IN THE GROIN WITHOUT CLINICAL SEQUELAE. 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
    240144 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK-NV-ONYX NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other