BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 4734991 · Received April 28, 2015

    Report

    Report Number
    2029214-2015-00449
    Event Type
    Injury
    Date Received
    April 28, 2015
    Date of Event
    November 11, 2011
    Report Date
    March 31, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/22079824. THE ONYX WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT; THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED, AND THE EVENT CAUSE COULD NOT BE DETERMINED. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. THE EVENT OCCURRED IN THE PATIENT POST PROCEDURE AND ITS CAUSE WAS UNKNOWN. NOTE: THE EVENTS ALSO OCCURRED DURING OFF LABEL USE OF THE ONYX. (B)(4).

    Description of Event or Problem · 1

    CITATION: MOHAMED SAMY ELHAMMADY, ET AL. PREOPERATIVE ONYX EMBOLIZATION OF VASCULAR HEAD AND NECK TUMORS BY DIRECT PUNCTURE. WORLD NEUROSURG. EPUB 2011 NOV 11. (2012) 77, 5/6:725-730. DOI:10.1016/J.WNEU.2011.02.033. THE FOLLOWING REPORT WAS RECEIVED BY MEDTRONIC (COVIDIEN) THROUGH REVIEW OF LITERATURE: THIRTEEN TUMORS WERE EMBOLIZED WITH ONYX 18, ONE WAS EMBOLIZED WITH ONYX 34, AND FOUR WERE EMBOLIZED WITH BOTH ONYX 18 AND 34. THE AVERAGE VOLUME OF ONYX USED PER CASE WAS 8.4 ML. ONE PATIENT UNDERWENT A BICORONAL CRANIOTOMY AND AN ATTEMPTED RESECTION OF THE LESION WHICH PROVED TO BE EXTREMELY DIFFICULT DUE TO THE HIGH TUMOR VASCULARITY. PUNCTURE OF THE TUMOR WAS THEN PERFORMED UNDER DIRECT VISION FOLLOWED BY EMBOLIZATION USING ONYX-18 UNDER SINGLE PLANE LATERAL FLUOROSCOPIC GUIDANCE. A FINAL ANGIOGRAM DEMONSTRATED APPROXIMATELY 50% DEVASCULARIZATION OF THE TUMOR WITH SOME ONYX MATERIAL WITHIN THE SUPERIOR SAGITTAL SINUS (FIGURE 3F). A GROSS TOTAL RESECTION OF THE LESION WAS SUBSEQUENTLY PERFORMED WITH A NOTICEABLE DECREASE IN TUMOR VASCULARITY FOLLOWING EMBOLIZATION. THE PATIENT AWOKE FROM ANESTHESIA WITHOUT APPARENT NEUROLOGICAL DEFICITS BUT DETERIORATED THE FOLLOWING DAY. A COMPUTED TOMOGRAPHIC AND MAGNETIC RESONANCE IMAGING/MAGNETIC RESONANCE VENOGRAPHIC SCAN DEMONSTRATED MASSIVE RIGHT FRONTAL EDEMA WITH MASS EFFECT AND OCCLUSION OF THE MIDSUPERIOR SAGITTAL SINUS. THE PATIENT REQUIRED AN EMERGENT DECOMPRESSIVE CRANIECTOMY; HOWEVER, 5 DAYS LATER SHE DEVELOPED A RIGHT FRONTAL HEMORRHAGIC INFARCTION AND REQUIRED A FRONTAL LOBECTOMY. THE PATIENT SUFFERED A DENSE LEFT HEMIPARESIS AND AFTER A PROLONGED AND COMPLICATED HOSPITAL STAY WAS DISCHARGED TO A REHABILITATION FACILITY. WITHIN 6 MONTHS THE PATIENT MADE A REMARKABLE RECOVERY. SHE IS CURRENTLY NEUROLOGICALLY INTACT AND HAS RECENTLY RETURNED TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277803 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-7100-060

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R| S