BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 4897225 · Received July 7, 2015

    Report

    Report Number
    2029214-2015-00764
    Event Type
    Injury
    Date Received
    July 7, 2015
    Date of Event
    April 11, 2015
    Report Date
    June 9, 2015
    Manufacturer
    IRVINE
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ONYX WAS NOT RETURNED FOR EVALUATION AS THEY WERE CONSUMED IN THE EVENTS. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECTS OF THE DEVICES DURING USE. THE EVENTS OCCURRED IN THE PATIENTS POST PROCEDURE AND THEIR CAUSES WERE UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    CITATION: DESHAIES E, SINGLA A, ALLOTT G, MARK R, ET AL. MULTIMODALITY INTRAOPERATIVE NEUROPHYSIOLOGICAL MONITORING DURING ONYX EMBOLIZATION OF CEREBROVASCULAR MALFORMATIONS. THE NEURODIAGNOSTIC JOURNAL. 11-APR-2015:(55)1:12-24 THE FOLLOWING REPORT WAS RECEIVED THROUGH REVIEW OF LITERATURE. TWENTY EIGHT PATIENTS (15 MALES, 13 FEMALES) WITH 24 AVMS (SPETZLER¿MARTIN GRADES 2-5) AND 4 DAVFS WERE REVIEWED FOR THIS STUDY. A RETROSPECTIVE REVIEW WAS CONDUCTED WHICH INCLUDED CONSECUTIVE PATIENTS WITH CEREBROVASCULAR MALFORMATIONS TREATED WITH ONYX. (ETHYLENE VINYL ALCOHOL COPOLYMER, DISSOLVED IN DIMETHYL SULFOXIDE) EMBOLIZATION UNDER GENERAL ANESTHESIA WITH IONM (INTRAOPERATIVE NEUROPHYSIOLOGICAL MONITORING) FROM 2009 TO 2012. SOMATOSENSORY EVOKED POTENTIALS (SSEPS), TRANSCRANIAL MOTOR EVOKED POTENTIALS (TCMEPS), VISUAL EVOKED POTENTIAL (VEPS), AUDITORY BRAINSTEM RESPONSE (ABR), AND ELECTROENCEPHALOGRAPHY (EEG) WERE USED SELECTIVELY IN ALL PATIENTS DEPENDING ON THE LOCATION OF THE MALFORMATION. PROVOCATIVE TESTING COMBINED WITH IONM WAS PERFORMED IN 28 PATIENTS OVER 75 SESSIONS. IT WAS REPORTED THAT THREE VESSELS, IN TWO PATIENTS, DEMONSTRATED CHANGES IN BASELINE SSEPS AFTER EMBOLIZATION OF FEEDING PEDICLES, DESPITE NORMAL IONM DURING PROVOCATIVE TESTING. BOTH PATIENTS HAD FRONTO-PARIETAL AVMS AND IN EACH CASE THE SSEPS OF THE MEDIAN NERVE WERE REDUCED BY APPROXIMATELY 50% AFTER EMBOLIZATION. BOTH PATIENTS EXHIBITED PERSISTENT CONTRALATERAL WEAKNESS AFTER THE PROCEDURE. ANGIOGRAPHICALLY, THE IONM CHANGES COINCIDED WITH POSTEMBOLIZATION RETROGRADE THROMBOSIS IN THE PROXIMAL PARENT VESSEL THAT PRECEDED THE POINT OF TESTING. SIX OF THOSE EIGHT PATIENTS DEVELOPED NEW VISUAL DEFICITS AFTER ARTERIAL OCCLUSION DESPITE UNCHANGED VEPS AND OCCIPITAL EEG DURING PROVOCATIVE TESTING AND ONYX EMBOLIZATION. FIVE OF THE EIGHT DEMONSTRATED FLUCTUATING VISUAL SYMPTOMS ON EXAMINATION DURING THE FIRST 24 HOURS AFTER EMBOLIZATION. THREE PATIENTS DEVELOPED PERMANENT CONTRALATERAL HOMONYMOUS HEMIANOPSIAS (AVMS), ONE PATIENT RETAINED IPSILATERAL CENTRAL RETINAL VISION ONLY (OPHTHALMIC ARTERY DAVF), AND ONE PATIENT HAD A CONTRALATERAL HOMONYMOUS QUADRANTANOPSIA THAT COMPLETELY RESOLVED AFTER 24 HOURS (AVM). THE SIXTH PATIENT (AVM) DEVELOPED A PERMANENT CONTRALATERAL HOMONYMOUS HEMIANOPSIA EIGHT DAYS AFTER EMBOLIZATION, PRIOR TO WHICH THERE WERE NO VISION CHANGES; MRI REVEALED A NEW OCCIPITAL INFARCT. TWO PATIENTS WITH CEREBELLAR AVMS DEVELOPED POSTPROCEDURAL STROKES. ONE PATIENT DEVELOPED SLIGHT UPPER EXTREMITY WEAKNESS AND DYSMETRIA AFTER EMBOLIZATION OF TWO FEEDING PEDICLES. THIS PATIENT IMPROVED UPON FOLLOW-UP AND UNDERWENT FURTHER ENDOVASCULAR EMBOLIZATION OF FEEDING PEDICLES WITHOUT SEQUELAE. THE SECOND PATIENT SIMILARLY HAD TWO FEEDING PEDICLES EMBOLIZED WITHOUT ANY PROCEDURAL COMPLICATIONS. POSTOPERATIVELY, SHE EXHIBITED CONTRALATERAL FACIAL WEAKNESS AND HEMIPARESIS, AND AN MRI ON THE FOURTH DAY AFTER EMBOLIZATION REVEALED AN ACUTE CEREBELLAR INFARCT. HER STRENGTH IMPROVED IN REHABILITATION, BUT DYSMETRIA PERSISTED THROUGH 18 MONTHS OF FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438426 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE IRVINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability