BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX

    MDR report key: 6443267 · Received March 29, 2017

    Report

    Report Number
    2029214-2017-00270
    Event Type
    Malfunction
    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
    Product Problem
    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 THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTED THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. 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. 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

    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 DURING THE EMBOLIZATION TREATMENT, ONYX MIGRATION INTO THE HEART. IT WAS REPORTED THAT THIS PATIENT WITH DURAL AVFS INVOLVING THE TRANSVERSE-SIGMOID SINUS (TS). THE PATIENT WAS TREATED VIA THE POSTERIOR BRANCH OF THE LEFT MIDDLE MENINGEAL ARTERY (MMA) USING ONYX-18. AFTER INJECTION OF 0.5 ML ONYX UNDER ROAD-MAPPING VIA THE LEFT MMA, DID NOT OBSERVE THE RADIO OPACITY OF ONYX. CHECKED THE PATIENT¿S CHEST IMMEDIATELY USING X-RAY AND FOUND ONYX WINDING WITH HEART BEAT IN THE RIGHT VENTRICLE. AFTER WAITING A FEW MINUTES, INJECTED ONYX AGAIN AND IT BEGAN TO PENETRATE IN THE LESION. AFTER THE PROCEDURE, B-ULTRASOUND EXAMINATION DEMONSTRATED A FOREIGN BODY IN THE RIGHT HEART VENTRICLE. PATIENT WAS MONITORING CLOSELY BECAUSE SHE WAS ASYMPTOMATIC. IN THIS STUDY BETWEEN FEBRUARY 2007 AND AUGUST 2008, 48 PATIENTS WERE TREATED FOR DURAL ARTERIOVENOUS FISTULA BY ARTERIAL AND 17 PATIENTS BY VENOUS APPROACH. 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226776 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-7000-060 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Disability