BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 4519044 · Received February 16, 2015

    Report

    Report Number
    2029214-2015-00145
    Event Type
    Injury
    Date Received
    February 16, 2015
    Date of Event
    March 4, 2014
    Report Date
    January 19, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    PMA P030004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE WEBSITE: HTTP://WWW.SCIENCEDIRECT.COM/SCIENCE/ARTICLE/PII/S1726490114000203. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBERS WERE NOT REPORTED. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE IMPLANTED IN THE PATIENT; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. THERE WAS LIMITED INFORMATION ABOUT THE DEVICE AND/OR THE PATIENT, THEREFORE ALL MALFUNCTION EVENTS WERE CAPTURED IN THIS REPORT. REFERENCE: (B)(4). RELATED MDR 2029214-2015-00119 TO REPORT SERIOUS INJURY FROM THE SAME ARTICLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CITATION: LUO ET AL. TRANSARTERIAL ONYX EMBOLIZATION OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULAS: A SINGLE CENTER EXPERIENCE. JOURNAL OF THE CHINESE MEDICINE ASSOCIATION. 77(2014)184-189. COVIDIEN RECEIVED INFORMATION THROUGH LITERATURE REVIEW THAT FOUR PATIENTS EXPERIENCED PARTIAL EMBOLIZATION IN A STUDY OF TRANSARTERIAL EMBOLIZATION OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULAS (DAVFS). THE STUDY INVOLVED 14 PATIENTS (MEAN AGE 62, 9 MALES, MEAN CLINICAL FOLLOW-UP WAS 16 MONTHS) TREATED BETWEEN 2009 AND 2012. PARTIAL EMBOLIZATION OCCURRED IN 4 PATIENTS. OF THE FOUR PARTIAL EMBOLIZATIONS, TWO WERE TYPE IIA+B, AND AFTER EMBOLIZATION ONE WAS REGRADED TO TYPE IIA. ANOTHER ONE WAS REGRADED TO TYPE IA; AN ADDITIONAL TWO PATIENTS UNDERWENT RADIOSURGERY (GAMMA KNIFE) AND ONE WAS CURED BY THE 24-MONTH FOLLOW-UP, WHEREAS ONE PATIENT WAS STILL WAITING FOR THE EFFECT OF RADIOSURGERY. NO SIGNIFICANT PERIPROCEDURAL COMPLICATION WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111957 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention