BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX, AVM

    MDR report key: 2180105 · Received July 27, 2011

    Report

    Report Number
    2029214-2011-00196
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 25, 2010
    Report Date
    June 27, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE CONSUMED IN THE EVENT.(B)(4)

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM (B)(6) STUDY. PER UPDATED INFORMATION RECEIVED ON (B)(6) 2013, HIGHER CEREBRAL DYSFUNCTION WAS OBSERVED AFTER THE AVM (ARTERIOVENOUS MALFORMATION) WAS COMPLETELY EXCISED ON (B)(6) 2010. A FOLLOW UP WAS PERFORMED ON (B)(6) 2011 AND IT SHOWED THAT THE HIGHER CEREBRAL DYSFUNCTION WAS SUBSIDING WHILE THE CEREBRAL INFARCTION REMAINED UNCHANGED. ACCORDING TO THE 12 AND 24 MONTH FOLLOW UPS, IT WAS CONFIRMED THAT BOTH HIGHER CEREBRAL DYSFUNCTION AND CEREBRAL INFARCTION REMAINED UNCHANGED. THE PHYSICIAN COMMENTED THAT THE CEREBRAL INFARCTION WAS INCURABLE AND THAT THERE WAS NO CASUAL RELATIONSHIP BETWEEN THESE COMPLICATIONS AND ONYX.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S AVM WAS TREATED WITH TWO VIALS OF ONYX VIA THREE MARATHON CATHETERS. DURING PROCEDURE, THE THALAMUS WAS OCCLUDED DUE TO UNEXPECTED ONYX MIGRATION. CONSEQUENTLY, THE PATIENT SUFFERED CEREBRAL INFARCTION. NO OTHER COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX, AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-060 8133199 (2 EA)

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Disability