BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6458020 · Received April 4, 2017

    Report

    Report Number
    2029214-2017-00365
    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
    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 INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. 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: 2029214-2017-00359, 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 PATIENT WITH 4-CM RIGHT PARIETOOCCIPITAL AVM (SPETZLER AND MARTIN GRADE III) WAS EMBOLIZED WITH ONYX, AND 90% OF THE NIDUS WAS OBLITERATED. THE PRINCIPAL DRAINING VEIN REMAINED OPEN. IMMEDIATELY AFTER EMBOLIZATION THE PATIENT COMPLAINED OF HEADACHE. CT SCANNING WAS NORMAL. HOWEVER, THE HEADACHE BECAME WORSE AND REPEATED CT SCANS 3 HOURS LATER SHOWED A HEMATOMA. EMERGENCY SURGERY FOLLOWED WITH COMPLETE REMOVAL OF THE AVM REMNANT AND HEMATOMA. THE PATIENT MADE AN UNEVENTFUL RECOVERY AND NEUROLOGIC FOLLOW-UP 6 WEEKS LATER DEMONSTRATED ONLY A QUADRANTANOPSIA. 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
    240223 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK-NV-ONYX NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention