BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6443269 · Received March 29, 2017

    Report

    Report Number
    2029214-2017-00269
    Event Type
    Injury
    Date Received
    March 29, 2017
    Date of Event
    September 1, 2009
    Report Date
    October 17, 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

    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 2029214-2017-00272 2029214-2017-00273.

    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 DURING LITERATURE REVIEW THAT POST PROCEDURE OF THE EMBOLIZATION, ONYX MIGRATION INTO THE HEART. IT WAS REPORTED THAT THIS PATIENT WITH DURAL ANTERIOR VENOUS FISTULAS (DAVFS) INVOLVING THE TRANSVERSE-SIGMOID SINUS (TS) WAS TREATED WITH 0.8 ML ONYX VIA AN OCCIPITAL ARTERY APPROACH WITH RESIDUAL FISTULA. NINE MONTHS AFTER THE PROCEDURE, THE PATIENT DEVELOPED HEART PALPITATION. CHEST X-RAY FILM SHOWED A PIECE OF ONYX IN THE RIGHT VENTRICLE AND B-ULTRASOUND EXAMINATION REVEALED DYSFUNCTION OF THE TRICUSPID VALVE. THE ONYX WAS REMOVED BY CARDIAC SURGERY. AT 9 MONTHS FOLLOW UP MRS = 0 BETWEEN FEBRUARY 2007 AND AUGUST 2008, ONYX MIGRATION WAS ENCOUNTERED IN FIVE PATIENTS WITH DURAL AVFS TREATED ENDOVASCULARLY. PROCEDURES PERFORMED UNDER GENERAL ANESTHESIA CONSISTED OF TWO ARTERIAL APPROACHES AND THREE VENOUS APPROACHES. THEY COMPRISED TWO WOMEN AND THREE MEN, RANGING IN AGE FROM 28 TO 56 (MEAN 43.6 YEARS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226778 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-7000-060 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention