BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX

    MDR report key: 6443327 · Received March 29, 2017

    Report

    Report Number
    2029214-2017-00273
    Event Type
    Death
    Date Received
    March 29, 2017
    Date of Event
    September 1, 2009
    Report Date
    March 3, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    INTERNATIONAL NEURORADIOLOGY CITATION: ONYX MIGRATION IN THE ENDOVASCULAR MANAGEMENT OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULAS H.WANG, X. LV, C. JIANG ET. AL, 15: 301-308, 2009 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 EVENT: 2029214-2017-00269, 2029214-2017-00270, 2029214-2017-00271, AND 2029214-2017-00272. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION DURING LITERATURE REVIEW THAT POST PROCEDURE ONYX MIGRATION OCCLUDED THE DISTAL DRAINING VEIN AND MAY HAVE LED TO VENOUS VARIX RUPTURE. IT WAS REPORTED THAT THE PATIENT WITH A LEFT TENTORIAL DURAL AVF WAS TREATED TRANS VENOUSLY VIA THE INTERNAL JUGULAR VEIN-TRANSVERSE-SIGMOID SINUS-BASAL VEIN OF ROSENTHAL (IJV-TS-BVR) APPROACH. THIS PATIENT DID NOT WAKE UP AFTER THE PROCEDURE AND CT SCANNING SHOWED AN INTRACRANIAL HEMORRHAGE NEAR THE VARIX OF THE DRAINING VEIN. WE ATTRIBUTED THE HEMORRHAGE TO THE OCCLUSION OF THE LEPTOMENINGEAL VEIN. WHEN THE FISTULA WAS SUB TOTALLY OBLITERATED, ONYX MIGRATION OCCLUDED THE DISTAL DRAINING VEIN AND MAY HAVE LED TO VENOUS VARIX RUPTURE. THE PATIENT WAS TREATED WITH ONYX 18 OR ONYX 34 ONYX MIGRATION IN THE ENDOVASCULAR MANAGEMENT OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULAS H.WANG, X. LV, C. JIANG ET. AL IN THIS STUDY BETWEEN FEBRUARY 2007 AND AUGUST 2008, 48 PATIENTS WERE TREATED FOR DURAL ARTERIOVENOUS FISTULA BY ARTERIAL AND 17 PATIENTS BY VENOUS APPROACHES AT OUR HOSPITAL. ONYX MIGRATION WAS ENCOUNTERED IN FIVE PATIENTS WITH DURAL AVFS TREATED ENDOVASCULARLY. TWO PATIENTS WERE TREATED TRANS ARTERIALLY AND THREE WERE TREATED TRANSVENOUSLY WITH ONYX. THEY COMPRISED TWO WOMEN AND THREE MEN, RANGING IN AGE FROM 28 TO 56 (MEAN 43.6 YEARS) REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224766 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK-NV-ONYX NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death