BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX

    MDR report key: 6656402 · Received June 21, 2017

    Report

    Report Number
    2029214-2017-00818
    Event Type
    Death
    Date Received
    June 21, 2017
    Report Date
    May 24, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EMBOLIC MATERIAL WAS NOT RETURNED AS IT WAS CONSUMED IN THE PROCEDURE. IT IS POSSIBLE THAT THE HEMODYNAMIC CHANGES INDUCED BY THE EMBOLIZATION MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THERE IS NO ALLEGATION THAT THE EMBOLIC MATERIAL WAS DEFECTIVE OR THAT A MALFUNCTION OCCURRED DURING ITS USE. BASED ON THIS INFORMATION, IT IS UNKNOWN WHAT CAUSED THE HEMORRHAGE THAT LEAD TO THE DEATH. THERE IS NO EVIDENCE SUGGESTING THAT THE ONYX WAS DEFECTIVE, BUT RATHER THE ADVERSE EVENT THAT WAS LIKELY CAUSED BY THE PROCEDURE, THE ANATOMICAL LOCATION THAT WAS BEING EMBOLIZED AND THE PATIENT¿S UNDERLYING MEDICAL CONDITION. LINKED EVENT: 2029214-2017-00816, 2029214-2017-00817.

    Description of Event or Problem · 1

    CITATION: ¿PARENT ARTERY OCCLUSION WITH ONYX FOR DISTAL ANEURYSMS OF POSTERIOR INFERIOR CEREBELLAR ARTERY: A SINGLE-CENTRE EXPERIENCE IN A SERIES OF 15 PATIENTS¿ QI WU, HAN-DONG WANG, QING-RONG ZHANG, XIN ZHANG. MEDTRONIC RECEIVED REPORT THAT 13 WOMEN AND THE MEAN AGE WAS 47 ± 8 YEARS (AGE RANGE, 37-59 YEARS). ONE PATIENT WAS REPORTED TO HAVE EXPIRED AFTER THE PROCEDURE BECAUSE OF THE HEMORRHAGE. THE INTRAOPERATIVE ANGIOGRAM DEMONSTRATING HEMORRHAGE BEFORE THE LIQUID EMBOLIC INJECTION WAS PERFORMED. POSTOPERATIVE ANGIOGRAM DEMONSTRATING THE ANEURYSM AND PARENT ARTERY OCCLUDED COMPLETELY. HEAD CT SCAN IMMEDIATELY AFTER EMBOLIZATION DEMONSTRATING SUBARACHNOID HEMORRHAGE (SAH) AND INTRAVENTRICULAR HEMORRHAGE (IVH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437244 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death