BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6521286 · Received April 25, 2017

    Report

    Report Number
    2029214-2017-00573
    Event Type
    Injury
    Date Received
    April 25, 2017
    Report Date
    March 28, 2017
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EMBOLIC MATERIAL WAS NOT RETURNED FOR ANALYSIS. ATTEMPTS WERE MADE TO GATHER SPECIFIC INFORMATION, HOWEVER, OUR ATTEMPTS WERE UNSUCCESSFUL. BASED ON THE REPORTED INFORMATION, THERE IS NO ALLEGATION THAT A MALFUNCTION OR DEFICIENCY OF THE EMBOLIC MATERIAL OCCURRED DURING THE PROCEDURE. THERE IS NO EVIDENCE SUGGESTING THAT THE MATERIAL WAS DEFECTIVE, BUT RATHER A PROCEDURE AND PATIENT CONDITION RELATED EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CITATION: "TRIGEMINOCARDIAC REFLEX IN EMBOLIZATION OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULA" AMERICAN JOURNAL OF NEURORADIOLOGY OCTOBER 2007, 28 (9) 1769-1770; DOI: HTTPS://DOI.ORG/10.3174/AJNR.A0675. MEDTRONIC RECEIVED REPORT OF IMMEDIATE REPRODUCIBLE AND REFLEXIVE RESPONSE OF ASYSTOLE UPON STIMULATION OF ONYX INJECTION DURING EMBOLIZATION OF A TENTORIAL DURAL ARTERIOVENOUS FISTULA IN A (B)(6) MAN. UPON RECOGNITION OF THE REFLEXIVE RELATIONSHIP BETWEEN ONYX INJECTION AND INCREASED VAGAL TONE, THE PATIENT WAS GIVEN ANTICHOLINERGIC IN AN EFFORT TO BLOCK CHOLINERGIC HYPERACTIVITY. AFTER ATROPINE WAS GIVEN, NO FURTHER DYSRHYTHMIAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299937 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention