BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX AVM

    MDR report key: 1662675 · Received April 16, 2010

    Report

    Report Number
    2029214-2010-00068
    Event Type
    Death
    Date Received
    April 16, 2010
    Date of Event
    March 17, 2010
    Report Date
    March 17, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE CONSUMED IN THE EVENT. MODELS AND LOT NUMBERS OF THE ONYX INVOLVED: MODEL # 105-7000-065, LOT # 8119128, DOM: 11/16/2009, EXPIRATION: 11/01/2012. (B) (4)

    Description of Event or Problem · 1

    TREATMENT OF AN AVM. IT WAS REPORTED THE AVM WAS TREATED WITH ONYX THROUGH THE ULTRAFLOW CATHETER WITH APPROXIMATELY 1.5-2CM OF ONYX REFLUX. UPON CATHETER REMOVAL, THE PHYSICIAN NOTICE HIGHER FORCE REQUIRED AND STOPPED. ANOTHER ATTEMPT WAS MADE WHICH WAS NOT POSSIBLE AS THE PATIENT EXPERIENCED VASOSPASM AND THE PATIENT WAS ADMINISTERED NIMOTOP. A MICROSNARE WAS USED TO SUPPORT PULL BACKED THE CATHETER. IT WAS REPORTED THE CATHETER BROKE OFF 20CM FROM THE DISTAL TIP. THE BROKEN SEGMENT REMAINED IN THE PATIENT. IT WAS REPORTED THE PATIENT HAD A BLEED ON THE NIGHT OF THE PROCEDURE AND ANOTHER BLEED ON THE FOLLOWING DAY. TWO DAYS AFTER, THE PATIENT EXPIRED. SAME EVENT AS MDR # 2029214-2010-00067.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7000-065 8108427

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death