BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 4907527 · Received July 10, 2015

    Report

    Report Number
    2029214-2015-00774
    Event Type
    Injury
    Date Received
    July 10, 2015
    Date of Event
    January 1, 2012
    Report Date
    June 12, 2015
    Manufacturer
    COVIDIEN
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARTICLE THAT USED TO CREATE THIS REPORT CAN BE FOUND AT HTTP://WWW.AJRONLINE.ORG/DOI/ABS/10.2214/AJR.10.5370. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECTS OF THE DEVICES DURING USE. THE EVENTS OCCURRED IN THE PATIENTS POST PROCEDURE AND THEIR CAUSES WERE UNKNOWN. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT REPORTED. (B)(4).

    Description of Event or Problem · 1

    CITATION: ANTOINE KHALIL, ET AL. PULMONARY ARTERY OCCLUSION WITH ETHYLENE VINYL ALCOHOL COPOLYMER IN PATIENTS WITH HEMOPTYSIS: INITIAL EXPERIENCE IN 12 CASES. AJR 2012; 198:207-212. JANUARY 2012, VOLUME 198, NUMBER 1 HTTP://WWW.AJRONLINE.ORG/DOI/ABS/10.2214/AJR.10.5370. THE FOLLOWING REPORT WAS RECEIVED BY MEDTRONIC (COVIDIEN) THROUGH REVIEW OF LITERATURE: ONE PATIENT HAD RECURRENCE OF HEMOPTYSIS 3 MONTHS AFTER INITIAL TREATMENT WITH ONYX DUE TO SYSTEMIC HYPERVASCULARIZATION RELATED TO THE PRESENCE OF ONYX IN THE NECROTIC AREA OF THE LUNG AND SEQUELAE OF PNEUMONIA AND REQUIRED EMERGENCY SURGERY. THE PATIENT WAS TREATED BY BRONCHIAL ARTERY EMBOLIZATION FOR THE FIRST OCCURENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451037 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN 105-7000-060

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R