BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 4714978 · Received April 21, 2015

    Report

    Report Number
    2029214-2015-00402
    Event Type
    Injury
    Date Received
    April 21, 2015
    Date of Event
    April 12, 2008
    Report Date
    March 25, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/18408923. THIS REPORT WAS CREATED TO CAPTURE SERIOUS INJURIES RELATED TO THE ONYX. ONYX WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE CONSUMED IN THE EVENT. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBERS WERE NOT REPORTED. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE ONYX DURING USE. THE EVENTS OCCURRED IN THE PATIENTS POST PROCEDURE AND THEIR CAUSES WERE UNKNOWN. (B)(4). INFORMATION RECEIVED FROM THE SAME ARTICLE AS MFR#S: 2029214-2015-00362, 2029214-2015-00363, 2029214-2015-00408, 2029214-2015-00407.

    Description of Event or Problem · 1

    CITATION: VASILIOS KATSARIDIS ET AL. CURATIVE EMBOLIZATION OF CEREBRAL ARTERIOVENOUS MALFORMATIONS (AVMS) WITH ONYX IN 101 PATIENTS. NEURORADIOLOGY (2008) 50:589-597. DOI 10.1007/S00234-008-0382-X THE FOLLOWING REPORT RECEIVED BY MEDTRONIC (COVIDIEN) THROUGH LITERATURE REVIEW: PATIENTS WHO WERE TREATED IN OUR DEPARTMENT WITH ONYX EMBOLIZATION FOR A BRAIN AVM FROM 1 JANUARY 2004 TO 31 DECEMBER 2007 (4 YEARS). 101 PATIENTS WERE IDENTIFIED (43 WOMEN, 58 MEN; MEAN AGE 38.8 YEARS; AGE RANGE 14-65). THIRTEEN PATIENTS (13/101, 12.9%) EXHIBITED A NEW FOCAL NEUROLOGICAL DEFICIT (LIMB PARESIS, APHASIA OR VISUAL DISTURBANCES) IN THE IMMEDIATE POST-OPERATIVE PERIOD. THE DEFICIT WAS TEMPORARY IN SEVEN CASES (6.9%) AND PERMANENT IN THE REMAINING SIX (5.9%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262927 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other| S