BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 4519062 · Received February 16, 2015

    Report

    Report Number
    2029214-2015-00119
    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 SERIOUS ADVERSE EVENTS WERE CAPTURED IN THIS REPORT. (B)(4). RELATED MDR 2029214-2015-00115 TO REPORT DEVICE MALFUNCTION FROM THE SAME ARTICLE.

    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 TWO PATIENTS HAD CATHETER DISRUPTIONS IN A STUDY OF TRANSARTERIAL ONYX EMBOLIZATION OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULAS (DAVFS). THE STUDY INVOLVED 14 PATIENTS (MEAN AGE 62 YEAR OLD, 9 MALES, MEAN CLINICAL FOLLOW-UP 16 MONTHS), TREATED BETWEEN 2009 AND 2012. THE TWO PATIENTS WHO EXPERIENCED ASYMPTOMATIC DISRUPTION AND RETENTION OF THE DISTAL SEGMENT OF THE MICROCATHETER TO FEEDERS OF EXTERNAL CAROTID ARTERIES HAD LONGER INJECTION TIME (45 MINUTES, 38 MINUTES) WITH LONG SEGMENTS OF ONYX REFLUX (4 CM, 3.5 CM). IT WAS REPORTED THAT THESE TWO OCCASIONS OF BREAKING AND RETENTION OF A DISTAL MICROCATHETER INTO A FEEDER OF THE OCCIPITAL ARTERIES DURING RETRIEVAL WERE ASSOCIATED WITH GREATER THAN 35 MINUTE INJECTIONS AND MORE THAN 3 CM REFLUX. THE AUTHORS REPORTED THAT THERE WAS NO SIGNIFICANT ARTERIAL INJURY SUCH AS DISSECTION, RUPTURE, OR BRAIN ISCHEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111940 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other