BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 8697444 · Received June 13, 2019

    Report

    Report Number
    2029214-2019-00554
    Event Type
    Injury
    Date Received
    June 13, 2019
    Date of Event
    March 28, 2019
    Report Date
    June 13, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ONYX WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. BASED ON THE REPORTED INFORMATION, THERE DOES NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. THE EVENT OCCURRED IN THE PATIENT POST-PROCEDURE AND ITS CAUSE COULD NOT BE CONCLUSIVELY DETERMINED FROM THE REPORTED INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    WANG, T., RICHARD, S. A., ZHANG, C. W., CHAOHUA, W., & XIE, X. D. (2019). DURAL ARTERIOVENOUS FISTULAS WITH PERIMEDULLARY VENOUS DRAINAGE SUCCESSFULLY MANAGED VIA ENDOVASCULAR ELECTROCOAGULATION. WORLD NEUROSURGERY, 126, 547-551. DOI:10.1016/J.WNEU.2019.03.223. MEDTRONIC RECEIVED A REPORT OF RETREATMENT AFTER ONYX EMBOLIZATION. THE PATIENT WAS ADMITTED 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. 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. SELECTIVE EMBOLIZATION OF THE MMA WAS PERFORMED WITH ONYX 18. IMMEDIATELY, DISAPPEARANCE OF THE SUPPLY OF THE RIGHT EXTERNAL CAROTID ARTERY WAS OBSERVED. INTRAOPERATIVELY, IT WAS 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. SIX MONTHS AFTER INITIAL TREATMENT, THE PATIENT WAS ADMITTED AGAIN FOR FURTHER EVALUATION. REPEATED 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 MENINGEAL ARTERY (MMA). THE PATIENT UNDERWENT ELECTROCOAGULATION THERAPY. THE LAST ANGIOGRAPHY DISPLAYED NO OPACIFICATION IN THE 2 FEEDING ARTERIES AND THE DRAINAGE VEINS. CEREBRAL ANGIOGRAPHY AND MRI PERFORMED 6 MONTHS LATER DEMONSTRATED THE DISAPPEARANCE OF THE DAVF. THE PATIENT¿S SYMPTOMS WERE ENTIRELY RELIEVED ON THE FIRST FELLOW-UP VISIT 6-MONTH AFTER THE SECOND OPERATION. TWO YEARS FOLLOW-UP REVEALED NO RECURRENCE OF THE DAVF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491541 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention