BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 6787668 · Received August 11, 2017

    Report

    Report Number
    2029214-2017-00960
    Event Type
    Injury
    Date Received
    August 11, 2017
    Report Date
    July 18, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MICROCATHETERS WAS NOT RETURNED FOR ANALYSIS, AND LIQUID EMBOLIC MATERIAL WAS CONSUMED IN THE EVENTS. BASED ON THE REPORTED INFORMATION, THE REPORT OF ENTRAPMENT COULD NOT BE CONFIRMED. THERE IS NO EVIDENCE SUGGESTING THAT THE LIQUID EMBOLIC MATERIAL WAS DEFECTIVE. IN THESE EVENTS, EXCESSIVE REFLUX AND THE PATIENT¿S ANATOMY LIKELY CONTRIBUTED TO THE REPORTED EVENT. PER THE LIQUID EMBOLIC MATERIAL INSTRUCTIONS FOR USE (IFU): DO NOT ALLOW MORE THAN 1 CM OF LIQUID EMBOLIC MATERIAL TO REFLUX BACK OVER CATHETER TIP. ANGIOARCHITECTURE, VASOSPASM, EXCESSIVE LIQUID EMBOLIC MATERIAL REFLUX, OR PROLONGED INJECTION TIME MAY RESULT IN DIFFICULT CATHETER REMOVAL AND CATHETER ENTRAPMENT. EXCESSIVE FORCE TO REMOVE AN ENTRAPPED CATHETER MAY CAUSE SERIOUS INTRACRANIAL HEMORRHAGE. THE LONG-TERM EFFECTS OF AN ENTRAPPED CATHETER THAT IS LEFT IN A PATIENT IS UNKNOWN, BUT COULD POTENTIALLY INCLUDE CLOT FORMATION, INFECTION OR CATHETER MIGRATION. LINKED EVENTS: 2029214-2017-00960 2029214-2017-00961

    Description of Event or Problem · 1

    CITATION: ¿SUCCESSFUL TRANSVENOUS EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS USING ONYX IN FIVE CONSECUTIVE PATIENTS¿ IRUENA KESSLER, MD, PHD. ROBERTO RIVA, MD. MARIA RUGGIERO, MD. MONICA MANISOR, MD. MAHER AL-KHAWALDEH, MD. CHARBEL MOUNAYER, MD, PHD. MEDTRONIC RECEIVED THE FOLLOWING REPORTS: PATIENT 1: A 32-YEAR-OLD MAN PRESENTED WITH CEREBRAL HEMORRHAGE. THE BAVM WAS COMPLETELY OCCLUDED, BUT THE MICROCATHETER WAS LEFT IN PLACE AND NOT REMOVED FROM THE TREATING VESSEL. POSTOPERATIVELY, THE PATIENT WAS UNCHANGED AND COULD PERFORM HIS DAILY LIFE ACTIVITIES NORMALLY (MRS SCORE = 0). FOLLOW-UP ANGIOGRAPHY AT 6 MONTHS SHOWED COMPLETE OBLITERATION OF THE BAVM. PATIENT 2: A (B)(6) YOUNG WOMAN PRESENTED WITH LEFT HEMIPARESIS ASSOCIATED WITH HEADACHE. THE NIDUS WAS PARTIALLY OCCLUDED, BUT THE MICROCATHETER WAS LEFT IN PLACE. POSTOPERATIVELY, THE PATIENT WAS CLINICALLY UNCHANGED (MRS SCORE = 2) AND WAS DISCHARGED. THE PATIENT WAS SENT TO A GK RADIOSURGERY SERVICE FOR ADJUNCTIVE TREATMENT, AND A FOLLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568176 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-7000-060

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability