BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 13815313 · Received March 18, 2022

    Report

    Report Number
    2029214-2022-00434
    Event Type
    Injury
    Date Received
    March 18, 2022
    Date of Event
    January 1, 2021
    Report Date
    March 17, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    SABINO LUZZI, MATTIA DEL MAESTRO, RENATO GALZIO; ACTA NEUROCHIRURGICA SUPPLEMENT; 2021; 132; THE PREOPERATIVE FUNCTIONAL DOWNGRADING OF BRAIN AVMS; DOI.ORG/10.1007/978-3-030-63453-7_16. MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE OF A REVIEW OF 31 PATIENT'S TREATED WITH ONYX 18 AND MARATHON CATHETERS HAD COMPLICATIONS. THE AVERAGE AGE WAS 36.9 AND THE MALE TO FEMALE RATION WAS 2.8.  THIRTY-ONE ARTERIOVENOUS MALFORMATIONS (AVMS) WERE EMBOLIZED IN 51 ENDOVASCULAR PROCEDURES. ONLY LOW-DENSITY ONYX18 WAS USED AS THE EMBOLIC AGENT IN THE PRESENT SERIES. THROUGH A TRANSARTERIAL TRANSFEMORAL APPROACH, A FLOW-DIRECTED MICROCATHETER AND A TAPERED MIC ROGUIDEWIRE WERE ADVANCED UNTIL THE NIDUS. AFTER A SUPERSELECTIVE CATHETERIZATION OF THE MAIN ARTERIAL FEEDERS, A MICROCATHETER WAS MOVED THROUGHOUT THE TARGET FEEDERS INSIDE THE NIDUS. WHILE PREFERRING THE DEEP-SEATED PARTS, ONYX WAS INJECTED WITH A FLOW RATE OF 0.1 ML/S BY MEANS OF THE ¿PLUG AND PUSH¿ TECHNIQUE. THE FIRST SESSION WAS ALWAYS AIMED TO ACHIEVE THE WIDEST OBLITERATION POSSIBLE VOLUME, STOPPING, HOWEVER, AFTER HAVING REACHED THE SAFEST FINAL POSSIBLE RESULT. TWO MECHANICAL AND ONE HEMODYNAMIC ENDOVASCULAR COMPLICATIONS WERE RECORDED DURING THE EMBOLIZATION SESSIONS; THE MECHANICAL ONES BOTH CONSISTED OF A CATHETER STUCK, WHILE A HEMIPARESIS OCCURRED IN A SINGLE PATIENT 8 H AFTER THE PROCEDURE. THE ESTIMATED EMBOLIZATION-RELATED MORBIDITY RATE WAS 3.2% WITH ZERO MORTALITY. AT THE 6-MONTH FOLLOW-UP, THE OVERALL OUTCOME WAS AS FOLLOWS: MRS 0¿2, MRS 3, AND MRS > 4 IN 77.5%, 19.3%, AND 3.2% OF THE PATIENTS, RESPECTIVELY. TWO PATIENTS (6.4%) HAD A SMALL REMNANT, WHICH UNDERWENT RADIOSURGERY. AS GRADE III TYPING CONCERNS, THE BEST OUTCOME WAS ACHIEVED IN SMALL AND MEDIUM-DEEP AVMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1923879 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 105-7100-060 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Required Intervention