BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 4810021 · Received June 1, 2015

    Report

    Report Number
    2029214-2015-00614
    Event Type
    Injury
    Date Received
    June 1, 2015
    Date of Event
    June 17, 2014
    Report Date
    May 5, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/24976101. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE OR A MALFUNCTION OF THE DEVICE OCCURRED DURING USE. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT REPORTED.(B)(4).

    Description of Event or Problem · 1

    CITATION: YU-HONE HSU, ET AL. ENDOVASCULAR TREATMENT AND COMPUTED IMAGING FOLLOW-UP OF 14 ANTERIOR CONDYLAR DURAL ARTERIOVENOUS FISTULAS. INTERV NEURORADIOL. 2014 MAY-JUN;20(3):368-77. DOI: 10.15274/NRJ-2014-10028. EPUB 2014 JUN 17. THE FOLLOWING REPORT WAS RECEIVED BY MEDTRONIC (COVIDIEN) THROUGH REVIEW OF LITERATURE: ONE PATIENT RECEIVED TRANSARTERIAL EMBOLIZATION (TAE) WITH LIQUID EMBOLIC AGENT (ONYX 18) WHICH FAILED AND THE PATIENT REQUIRED FURTHER TREATMENT WITH COILING. A TOTAL 14 PATIENTS (SEVEN MALES, SEVEN FEMALES) WERE TREATED, WITH A MEAN AGE OF 54.4 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353444 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-7000-060

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention