BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6696891 · Received July 10, 2017

    Report

    Report Number
    2029214-2017-00861
    Event Type
    Injury
    Date Received
    July 10, 2017
    Date of Event
    September 26, 2016
    Report Date
    June 12, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: JOOHYUN KIM, JANG-BO LEE, TAI-HYOUNG CHO, JUNSEOK W. HUR. INCIDENTAL OCCLUSION OF ANTERIOR SPINAL ARTERY DUE TO ONYX REFLUX IN EMBOLIZATION OF SPINAL TYPE II ARTERIOVENOUS MALFORMATION. EUR SPINE J (2017) 26. DOI 10.1007/S00586-016-4767-Y. PUBLISHED ONLINE: 26 SEPTEMBER 2016 THE ONYX WILL NOT RETURN AS IT WAS CONSUMED IN THE EVENT AND REMAINS IN THE PATIENT. THERE WAS LIMITED INFORMATION INCLUDED IN THE ARTICLE; THE MODEL AND LOT NUMBERS OF THE ONYX WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE CAUSE OF THE REPORTED EVENT CANNOT BE RELIABLY DETERMINED. HOWEVER, BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. 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 THROUGH LITERATURE REVIEW THAT THIS PATIENT EXPERIENCED ONYX RETROGRADE REFLUX, OCCLUDING THE ASA BRANCH. POST-OPERATIVE QUADRIPLEGIA AND IMPAIRMENT OF THE CRANIAL NERVE (CN) IX, X, XI, AND XII WAS OBSERVED. THE PATIENT WAS ADMITTED VIA THE EMERGENCY ROOM DUE TO A 1-DAY HISTORY OF PROGRESSIVE WEAKNESS AND PARESTHESIA IN THE BILATERAL UPPER AND LOWER EXTREMITIES. NEUROLOGIC EXAMINATION REVEALED MOTOR GRADE 4 FOR ALL EXTREMITIES. CERVICAL MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED IMMEDIATELY AND THE RESULT SUGGESTED A SPINAL AVM WITH EXTENSIVE MEDULLARY SWELLING. THE PATIENT SHOWED RAPID DETERIORATION OF NEUROLOGY WITHIN AN HOUR AFTER THE MRI WAS TAKEN (MOTOR GRADE 3). PROGRESSION OF SPINAL CORD COMPRESSION DUE TO MEDULLARY SWELLING WAS SUSPECTED, THEREFORE EMERGENCY MULTILEVEL LAMINOPLASTY WAS PERFORMED. THE PATIENT WAS STABLE AFTER THIS PROCEDURE. SPINAL ANGIOGRAPHY WAS PERFORMED AFTER THE SURGERY, DEMONSTRATED A SPINAL TYPE II AVM WITH TWO FEEDERS; THE RIGHT VA AND RIGHT DEEP CERVICAL ARTERY. THE NIDUS OF THE AVM AND CONGESTED MEDULLARY DRAINING VEINS WAS OBSERVED. ONYX EMBOLIZATION WAS PERFORMED TO TREAT THE AVM. SUCCESSFUL EMBOLIZATION OF THE NIDUS SUPPLIED FROM THE VA WAS OBSERVED WITH ONYX 0.2ML. THE MICROCATHETER WAS REPOSITIONED TO THE DEEP CERVICAL ARTERY AND ADVANCED CLOSE TO THE NIDUS, PASSING THE ASA BRANCH ORIFICE. LESS THAN 0.2ML OF ONYX WAS INJECTED, HOWEVER, UNEXPECTED RETROGRADE REFLUX OCCURRED AND ONYX INSTANTLY OCCLUDED THE ASA BRANCH. IMMEDIATE ANTICOAGULATION WITH HEPARIN (1000IG) WAS PERFORMED AND NO FURTHER EMBOLIZATION WAS ATTEMPTED. POST-OPERATIVE QUADRIPLEGIA AND IMPAIRMENTS OF CRANIAL NERVE S (CN) IX, X, XI, AND XII WERE REPORTED. AFTER DISCHARGE FROM THE ICU, THE PATIENT UNDERWENT REHABILITATION THERAPY, WHERE GRADUAL IMPROVEMENTS OF MOTOR DEFICITS AND LOW CN DYSFUNCTION WAS DEMONSTRATED. FOLLOW UP NEUROLOGIC EXAMINATION 1 YEAR POST-PROCEDURE SHOWED MARKED IMPROVEMENT OF BOTH MOTOR AND LOW CN FUNCTION. FOLLOW-UP MRI AT 1 YEAR REVEALED SIGNIFICANTLY IMPROVED CORD SWELLING COMPARED WITH THE INITIAL POSTOPERATIVE MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480185 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Disability