BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6501370 · Received April 18, 2017

    Report

    Report Number
    2029214-2017-00460
    Event Type
    Injury
    Date Received
    April 18, 2017
    Date of Event
    October 1, 2016
    Report Date
    March 23, 2017
    Manufacturer
    MEDTRONIC COVIDIEN
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. THE EVENT OCCURRED IN THE PATIENT POST PROCEDURE AND ITS CAUSE WAS UNKNOWN. CITATION: D. LE FOLL, H. RAOULTA. J.C. FERRÉA, ET AL. ¿THE LEARNING CURVE EFFECT ON EMBOLIZATION OF CEREBRAL DURAL ARTERIOVENOUS FISTULA SINGLE-CENTER EXPERIENCE IN 48 CONSECUTIVE PATIENTS.¿ JOURNAL OF NEURORADIOLOGY 2017; 44, 52¿56. HTTP://DX.DOI.ORG/10.1016/J.NEURAD.2016. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH REVIEW OF LITERATURE THAT TWO PATIENTS, BOTH OF WHOM WERE TREATED WITH ONYX, THERE WAS DURAL ARTERIOVENOUS FISTULAS (DAVF) RECURRENCE OR WORSENING. FROM MAY 2008 TO OCTOBER 2014, 57 EMBOLIZATION PROCEDURES WERE ATTEMPTED ON 48 PATIENTS (37 MEN AND 11 WOMEN; MEDIAN AGE: 63.9 YEARS) FOR DAVF IN A SINGLE CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282123 ONYX AGENT, INJECTABLE, EMBOLIC MFE MEDTRONIC COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other