BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 9218326 · Received October 22, 2019

    Report

    Report Number
    2029214-2019-01052
    Event Type
    Injury
    Date Received
    October 22, 2019
    Report Date
    October 22, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    TING WANG, SEIDU A. RICHARD, CHANG WEI ZHANG, WANG CHAOHUA, XIAO DONG XIE. DURAL ARTERIOVENOUS FISTULAS WITH PERIMEDULLARY VENOUS DRAINAGE SUCCESSFULLY MANAGED VIA ENDOVASCULAR ELECTROCOAGULATION. DOI: 10.1016/J.WNEU.2019.03.223. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF A PATIENT COMPLICATION AFTER THE USE OF ONYX. A (B)(6) MAN WAS ADMITTED AT OUR FACILITY WITH A 3-MONTH HISTORY OF PARESTHESIA IN THE LOWER LIMBS, WHICH PROGRESSIVE DETERIORATION FROM THE DISTAL TO THE PROXIMAL. HE SUBSEQUENTLY COMPLAINED OF NUMBNESS IN THE RIGHT HAND. PHYSICAL EXAMINATION REVEALED HYPERTONIA IN RIGHT LOWER LIMB. ROMBERG SIGN AND BILATERAL BABINSKI SIGNS, DONE SIMULTANEOUSLY, REVEALED BILATERAL HYPALGESIA BELOW THE LEVEL OF THE SIXTH THORACIC VERTEBRA. A 6-VESSEL CEREBRAL ANGIOGRAPHY DEMONSTRATED A CRANIAL DAVF ON THE DORSAL SELLAE EXTENDING TO AREAS SUPPLIED BY THE RIGHT MENINGOHYPOPHYSEAL TRUNK (MHT), RECURRENT MENINGEAL BRANCH OF RIGHT OPHTHALMIC ARTERY (OA), AS WELL AS THE POSTERIOR BRANCH OF RIGHT MMA, WITH VENOUS DRAINAGE INTO THE PRE- AND RETRO-MEDULLARY VEINS. INTRAOPERATIVELY, WE NOTED THAT SELECTIVE CATHETERIZATION OF THE MHT AND OPHTHALMIC MENINGEAL BRANCH WERE EXTREMELY DIFFICULT. THEREFORE, SELECTIVE EMBOLIZATION OF THE MMA WAS PERFORMED WITH ONYX 18. IMMEDIATELY, WE OBSERVED A DISAPPEARANCE OF THE SUPPLY OF THE RIGHT EXTERNAL CAROTID ARTERY. INTRAOPERATIVELY, WE OBSERVED THAT THE VENOUS DRAINAGE WAS STILL FILLED WITH CONTRAST VIA BRANCHES OF THE INTERNAL CAROTID ARTERY DUE TO THE FAILURE OF FISTULA OCCLUSION. AFTER THE FIRST PROCEDURE, THE PATIENT¿S SYMPTOMS WERE RELIEVED FOR ABOUT 20 DAYS,WITH SUBSEQUENT AGGRESSIVE DETERIORATION OF SIGNS AND SYMPTOMS. THE PATIENT WAS ADMITTED TO OUR DEPARTMENT AGAIN FOR FURTHER EVALUATION AND TREATMENT 6 MONTHS AFTER THE INITIAL TREATMENT. A REPEATED 6- VESSEL CEREBRAL ANGIOGRAM REVEALED THE CEREBRAL DAVF WAS STILL PRESENT, WITH THE MAIN BLOOD SUPPLY BEING THE RIGHT MHT AND OPHTHALMIC MENINGEAL BRANCH OF RIGHT OA AS WELL AS THE POSTERIOR BRANCH OF RIGHT MIDDLE M ENINGEAL ARTERY (MMA). MULTIPLE ATTEMPTS TO ADVANCE THE MARATHON FLOW-DIRECTED MICROCATHETER (MEDTRONIC, MINNEAPOLIS, MINNESOTA, USA) AS CLOSE AS POSSIBLE TO THE FISTULA LOCATION FAILED; THEREFORE, WE ADOPTED ELECTROCOAGULATION THERAPY. CEREBRAL ANGIOGRAPHY AND MRI PERFORMED 6 MONTHS LATER DEMONSTRATED THE DISAPPEARANCE OF THE DAVF AS WELL AS THE HIGH SIGNALS OF MEDULLA OBLONGATA AND UPPER CERVICAL SPINAL CORD. THE PATIENT¿S SYMPTOMS WERE ENTIRELY RELIEVED ON THE FIRST FELLOW-UP VISIT 6-MONTH AFTER THE SECOND OPERATION. TWO YEARS FOLLOWUP REVEALED NO RECURRENCE OF THE DAVF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012398 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX NOT-REP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention