BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 2972254 · Received February 21, 2013

    Report

    Report Number
    2029214-2013-00146
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TREATMENT OF A FACIAL AVM (ARTERIOVENOUS MALFORMATION). DURING ONYX INJECTION FOR THE SECOND TARGET VESSEL OF THE AVM, IT WAS REPORTED THAT ONYX LEAKED FROM A RUPTURE ON THE APOLLO CATHETER AND EMBOLIZED AN UNINTENDED VESSEL. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75398 ONYX LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7200-060 9677585

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability