BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6348229 · Received February 21, 2017

    Report

    Report Number
    2029214-2017-00130
    Event Type
    Injury
    Date Received
    February 21, 2017
    Date of Event
    June 6, 2016
    Report Date
    January 30, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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

    CITATION: KASRA KHATIBI, OMAR CHOUDHRI, IAN D. CONNOLLY, RYAN A. MCTAGGART, HUY M. DO. ASYSTOLE DURING ONYX EMBOLIZATION OF A PEDIATRIC ARTERIOVENOUS MALFORMATION: A SEVERE CASE OF THE TRIGEMINOCARDIAC REFLEX. WORLD NEUROSURGERY. 2016. THE ONYX MODEL AND LOT NUMBER WERE NOT PROVIDED. THE ONYX WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS IMPLANTED IN THE PATIENT. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE ANATOMICAL LOCATION OF THE ONYX DELIVERY INCLUDED THE SENSORY RECEPTIVE FIELD OF THE TRIGEMINAL NERVE, IN THE FACIAL OR DURAL SEGMENTS. THE AUTHORS CONCLUDED THAT TCR CAN BE TRIGGERED BY STIMULATION OF THE TRIGEMINAL SENSORY RECEPTIVE FIELD DURING ONYX EMBOLIZATION OF AVMS AND DURAL ARTERIOVENOUS FISTULA (DAVF) IN ADULTS AND PEDIATRIC PATIENTS. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. MDRS ASSOCIATED TO THIS LITERATURE REVIEW: 2029214-2017-00129, 2029214-2017-00130, 2029214-2017-00131, 2029214-2017-00132, 2029214-2 017-00133, 2029214-2017-00134, 2029214-2017-00135, 2029214-2017-00136, 2029214-2017-00137, 2029214-2017-00138, 2029214-2017-00139. 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

    THE TCR OCCURRED WITH THE DMSO INJECTION. THE PROCEDURE WAS TO USE ONYX EMBOLIZATION TO TREAT A HEAD AND NECK TUMOR OUTSIDE THE DURA.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW THAT A (B)(6) MALE PATIENT EXPERIENCED TRIGEMINAL-CARDIAC REFLEX (TCR) DURING AN ONYX EMBOLIZATION PROCEDURE TO TREAT A JUVENILE NASOPHARYNGEAL ANGIOFIBROMA (JNA). THE NIDUS LOCATION WAS IN THE LEFT NASOPHARYNX WITH ARTERIAL SUPPLY FROM THE LEFT INTERNAL MAXILLARY ARTERY (IMA). THE JNA TREATMENT STRATEGY WAS TRANSARTERIAL VIA THE RIGHT IMA. THE TCR WAS MANAGED WITH INJECTION CESSATION AND IV ATROPINE. THE OUTCOME WAS HEMODYNAMIC STABILITY (HDS) WITH NO RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129551 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention