BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 2010322 · Received March 8, 2011

    Report

    Report Number
    2029214-2011-00046
    Event Type
    Injury
    Date Received
    March 8, 2011
    Report Date
    February 9, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN AVM. IT WAS REPORTED THAT THE PATIENT'S AVM WAS TREATED WITH ONYX AND THE CATHETER WAS LEFT INSIDE THE PATIENT DUE TO ENTRAPMENT. THREE YEARS AFTER THE TREATMENT, THE PATIENT CAME BACK AND REPORT THE CATHETER HAS INDUCED PATIENT INJURY DUE TO THE CATHETER WAS LEFT INSIDE THE ARTERY (LEG THROMBOPHLEBITIS AND NECROSIS AT THE LEVEL OF THE HEEL). THE CATHETER WAS REMOVED VIA SURGERY AND THE PATIENT HAS RECOVERED. NO OTHER COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULT OF THE EVENT. SAME EVENT AS MDR# 2029214-2011-00045.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention