BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX, AVM

    MDR report key: 755297 · Received August 25, 2006

    Report

    Report Number
    2029214-2006-00100
    Event Type
    Death
    Date Received
    August 25, 2006
    Date of Event
    July 24, 2006
    Report Date
    July 26, 2006
    Manufacturer
    EV3 NEUROVASCULAR DIVISION
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ONYX IN THIS CASE COULD NOT BE RETURNED FOR EVALUATION. BASED ON THE INITIAL REPORT, THE DEVICE DOES NOT APPEAR TO HAVE MALFUNCTIONED. THE DEVICE HISTORY RECORDS FOR THE REPORTED PRODUCT LOTS NUMBERS HAVE BEEN REVIEWED AND NO QUALITY ISSUES WERE NOTED. THE PRODUCT MET THE ACCEPTANCE CRITERIA PRIOR TO RELEASE. MODEL AND LOT NUMBERS WERE INVOLVED:ADD'L MODEL# 105-7100-060; 105-7100-080. ADD'L LOT# 1561150; 1138969. ADD'L DATE:2006; 2005. ADD'L MFR EXPIRATION:09-2008; 09-2007.

    Description of Event or Problem · 1

    PRE-OPERATIVELY THE PT PRESENT WITH A GRADE 4 AVM, USING THE SPELTZER-MARTIN SYSTEM AND TREATED WITH ONYX IN TWO STAGES. FIRST STAGE WITH 1 VIAL OF ONYX 18 IN 2006, AND 2ND STAGE WITH 2 VIALS OF ONYX 18 AND 1 VIAL OF ONYX 34 EIGHTEEN DAYS LATER. APPROX 25% OF THE AVM WAS EMBOLIZED. PT RELEASED FROM HOSP TWO DAYS LATER, AND READMITTED TO ER IN THE SAME MONTH, WITH SYMPTOMS OF DEHYDRATION AND HERNIATED IN THE BRAIN AND SUBSEQUENTLY DEATH THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX, AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR DIVISION 105-7100-060 651495

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death