BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 5769385 · Received July 5, 2016

    Report

    Report Number
    2029214-2016-00499
    Event Type
    Injury
    Date Received
    July 5, 2016
    Report Date
    June 6, 2016
    Manufacturer
    MEDTRONIC COVIDIEN
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: L. H. DE CASTRO-AFONSO, G. S. NAKIRI, R. S. OLIVEIRA, ET AL. "CURATIVE EMBOLIZATION OF PEDIATRIC INTRACRANIAL ARTERIOVENOUS MALFORMATIONS USING ONYX: THE ROLE OF NEW EMBOLIZATION TECHNIQUES ON PATIENT OUTCOMES." NEURORADIOLOGY (2016) 58:585¿594. DOI 10.1 007/S00234-016-1666-1. 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 AND THE EVENT CAUSE WAS UNKNOWN. INFORMATION RECEIVED FROM THE SAME REPORT AS MFR: 2029214-2016-00500 2029214-2016-00501.

    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 LITERATURE REVIEW THAT A VENTRICULAR HEMORRHAGE OCCURRED DURING EMBOLIZATION TREATMENT OF AN INTRACRANIAL AVM WITH ONYX. THE HEMORRHAGE WAS MANAGED BY IMMEDIATE EMBOLIZATION USING ANOTHER MANUFACTURER EMBOLIC AGENT FOLLOWED BY AN EXTERNAL VENTRICULAR DRAINAGE. THE PATIENT WAS DISCHARGED AFTER 10 DAYS WITH ATAXIA AND AFTER 6 MONTHS SHE PRESENTED A SIGNIFICANT FUNCTION IMPROVEMENT WITH MILD SYMPTOMS OF VERTIGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423534 ONYX AGENT, INJECTABLE, EMBOLIC MFE MEDTRONIC COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention