BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 4895718 · Received July 7, 2015

    Report

    Report Number
    2029214-2015-00759
    Event Type
    Injury
    Date Received
    July 7, 2015
    Date of Event
    March 27, 2015
    Report Date
    June 9, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/25816081.THE ONYX WAS NOT RETURNED FOR EVALUATION AS THEY WERE CONSUMED IN THE EVENTS. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE ONYX WAS DEFECTIVE, BUT RATHER PROCEDURE RELATED AND POST PROCEDURE EVENTS AND THEIR CAUSES WERE UNKNOWN.(B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ARTICLE: R. WEBSTER CROWLEY, ET AL. NEUROLOGICAL MORBIDITY AND MORTALITY ASSOCIATED WITH THE ENDOVASCULAR TREATMENT OF CEREBRAL ARTERIOVENOUS MALFORMATIONS BEFORE AND DURING THE ONYX ERA. J NEUROSURG 122:1492-1497, 2015. PUBLISHED ONLINE MARCH 27, 2015; DOI: 10.3171/2015.2.JNS131368. THE FOLLOWING REPORT WAS RECEIVED BY MEDTRONIC (COVIDIEN) THROUGH REVIEW OF LITERATURE. A RETROSPECTIVE REVIEW WAS PERFORMED OF ALL PATIENTS WITH CEREBRAL AVMS UNDERGOING EMBOLIZATION AT THE BARROW NEUROLOGICAL INSTITUTE FROM 1995 TO 2012. ENDOVASCULAR TREATMENT OF 342 CEREBRAL AVMS (ARTERIOVENOUS MALFORMATION) WAS PERFORMED OVER 446 TREATMENT SESSIONS (MEAN AGE 37.8 YEARS, RANGE 1-83 YEARS). THE PATIENTS WERE 55.3% FEMALE (N = 189) AND 44.7% MALE (N = 153). IT WAS REPORTED THAT UNEXPECTED PERIPROCEDURAL NEUROLOGICAL MORBIDITY WAS NOTED IN 8.6% OF ONYX CASES IN THIS SERIES AND SILENT COMPLICATIONS WERE PRESENT IN 9% OF ONYX THE CASES IN THIS SERIES. THERE WERE 4 CASES IN WHICH NBCA (N-BUTYL CYANOACRYLATE) WAS USED EXPEDITIOUSLY TO MANAGE VESSEL PERFORATION IN AN ONYX TREATMENT SESSION, BUT FOR WHICH IT WAS OTHERWISE NOT USED. THE BRAND AND MODEL OF THE MICROCATHETERS USED IN THESE PROCEDURES WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439972 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other| R| S