BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 10909220 · Received November 26, 2020

    Report

    Report Number
    2029214-2020-01196
    Event Type
    Injury
    Date Received
    November 26, 2020
    Date of Event
    October 6, 2020
    Report Date
    November 25, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT DURING THE INITIAL EMBOLIZATION, THE DOCTOR COMPLAINED OF THE ONYX NOT FEELING SMOOTH, THE INJECTION WAS COMING IN COLUMNS, BREAKING OFF, AND POOR VISUALIZATION . THE SPEED SETTING ON THE SHAKER WAS 8, AND THE ONYX WAS SHAKEN FOR MORE THAN 20 MINUTES. IT WAS NOTED THE VIALS DID NOT SIT FOR MORE THAN FIVE MINUTES PRIOR TO INJECTION SINCE INJECTION WAS PERFORMED IMMEDIATELY AFTER SHAKING. THE ONYX WAS CHANGED OUT TO CONTINUE EMBOLIZATION. LATER IN THE PROCEDURE, THE DOCTOR DECIDED TO EMBOLIZE A DIFFERENT FEEDER TO THE ARTERIOVENOUS MALFORMATION (AVM), BUT UPON CONNECTING THE SYRINGE, THERE WAS HIGH RESISTANCE DUE TO CATHETER OCCLUSION, AND THE DOCTOR WAS UNABLE TO VISUALIZE THE ONYX AGAIN. INJECTION WAS STOPPED, AND THE CATHETER WAS CHANGED OUT. THE VESSEL WAS RE-CATHETERIZED, AND A DIFFERENT BATCH OF ONYX WAS PREPARED. EMBOLIZATION WENT AS NORMAL, BUT WHEN PULLING THE CATHETER OUT AFTER A FEW MINUTES OF INJECTION, THE PATIENT ENCOUNTERED A BLEED IN THE VESSEL. THE VESSEL WAS ACCESSED AGAIN, AND THE BLEED WAS SUCCESSFULLY ARRESTED. IT WAS UNCLEAR IF THERE WAS ANY ISSUE WITH THE CATHETER OR ONYX. HOWEVER, IT WAS REALIZED THE ONYX VIALS LOT NUMBER WAS A976615 WHILE THE PACKAGING STATED A992791. POST-PROCEDURE EXPERT COMPUTERIZED TOMOGRAPHY (CT) IMAGING SHOWED THE PATIENT HAD A SMALL SUBDURAL AND SUBARACHNOID BLEEDING. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ARTERIOVENOUS MALFORMATION (AVM) IN THE ELOQUENT REGION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT ONLY 4 OF THE 10 VIALS USED HAD THE PACKAGING ISSUE. THERE HAD BEEN NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE SECOND CATHETER USED WAS AN APOLLO. A CAUSE FOR THE BLEED IN THE VESSEL WAS NOT DETERMINED, THOUGH THE DOCTOR THEORIZED IT MAY HAVE BEEN A VASOSPASM. THE PATIENT WAS RECOVERING FROM THE PROCEDURE. NO ADDITIONAL ADVERSE EVENTS OR ANY MEDICAL/SURGICAL INTERVENTIONS HAVE BEEN PERFORMED TO TREAT THE HEMORRHAGING. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS CURRENTLY RECOVERING. THERE HAD BEEN NO LONG PAUSES OF OVER 2 MINUTES DURING THE INJECTION. THERE WAS NO RESISTANCE NOTED DURING THE DMSO INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1374550 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 105-7000-060 A992791

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention