BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 12808059 · Received November 12, 2021

    Report

    Report Number
    2029214-2021-01464
    Event Type
    Injury
    Date Received
    November 12, 2021
    Date of Event
    February 1, 2021
    Report Date
    November 12, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED PATIENT AGE (44 YEARS) IS REPRESENTATIVE OF THE MEAN AGE FOR ALL PATIENTS INCLUDED IN THE STUDY ARTICLE. REPORTED PATIENT SEX (MALE) IS REPRESENTATIVE OF THE MAJORITY OF PATIENTS INCLUDED IN THE STUDY ARTICLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEYERS, P. M., FIFI, J. T., COCKROFT, K. M., MILLER, T. R., GIVEN, C. A., ZOMORODI, A. R., JAGADEESAN, B. D., MOKIN, M., KAN, P., YAO, T. L., DIAZ, O., HUDDLE, D., BELLON, R. J., SEINFELD, J., POLIFKA, A. J., FIORELLA, D., CHITALE, R. V., KVAMME, P., MORROW, J. T., ¿ AZIZ-SULTAN, M. A. (2021). SAFETY OF THE APOLLO ONYX DELIVERY MICROCATHETER FOR EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS: RESULTS FROM A PROSPECTIVE POST-MARKET STUDY. JOURNAL OF NEUROINTERVENTIONAL SURGERY, 13(10), 935¿941. HTTPS://DOI.ORG/10.1136/NEURINTSURG-2020-016830. ABSTRACT BACKGROUND: CATHETER RETENTION AND DIFFICULTY IN RETRIEVAL HAVE BEEN OBSERVED DURING EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS (BAVMS) WITH THE ONYX LIQUID EMBOLIC SYSTEM (ONYX). THE APOLLO ONYX DELIVERY MICROCATHETER (APOLLO) IS A SINGLE LUMEN CATHETER DESIGNED FOR CONTROLLED DELIVERY OF ONYX INTO THE NEUROVASCULATURE, WITH A DETACHABLE DISTAL TIP TO AID CATHETER RETRIEVAL. THIS STUDY EVALUATES THE SAFETY OF THE APOLLO FOR DELIVERY OF ONYX DURING EMBOLIZATION OF BAVMS. METHODS: THIS WAS A PROSPECTIVE, NON-RANDOMIZED, SINGLE-ARM, MULTICENTER, POST-MARKET STUDY OF PATIENTS WITH A BAVM WHO UNDERWENT ON YX EMBOLIZATION WITH THE APOLLO BETWEEN MAY 2015 AND FEBRUARY 2018. THE PRIMARY ENDPOINT WAS ANY CATHETER-RELATED ADVERSE EVENT (AE) AT 30 DAYS, SUCH AS UNINTENTIONAL TIP DETACHMENT OR MALFUNCTION WITH CLINICAL SEQUELAE, OR RETAINED CATHETER. PROCEDURE-RELATED AES (UNTOWARD MEDICAL OCCURRENCE, DISEASE, INJURY, OR CLINICAL SIGNS) AND SERIOUS AES (LIFE THREATENING ILLNESS OR INJURY, PERMANENT PHYSIOLOGICAL IMPAIRMENT, HOSPITALIZATION, OR REQUIRING INTERVENTION) WERE ALSO RECORDED. RESULTS: A TOTAL OF 112 PATIENTS WERE ENROLLED (MEAN AGE 44.1±17.6 YEARS, 56.3% MEN), AND 201 APOLLO DEVICES WERE USED IN 142 EMBOLIZATION PROCEDURES. THE MEAN SPETZLER¿MARTIN GRADE WAS 2.38. THE PRIMARY ENDPOINT WAS NOT OBSERVED (0/112, 0%). THE CATHETER TIP DETACHED DURING 83 (58.5%) PROCEDURES, OF WHICH 2 (2.4%) WERE UNINTENTIONAL AND DID NOT RESULT IN CLINICAL SEQUELAE. AT 30 DAYS, PROCEDURE RELATED AES OCCURRED IN 26 (23.2%) PATIENTS, AND PROCEDURE-RELATED SERIOUS AES IN 12 (10.7%). AT 12 MONTHS, THERE WERE 3 (2.7%) MORTALITIES, INCLUDING 2 (1.8%) NEUROLOGICAL DEATHS, NONE OF WHICH WERE DEVICE-RELATED. CONCLUSION: THIS STUDY DEMONSTRATES THE SAFETY OF APOLLO FOR ONYX EMBOLIZATION OF BAVMS. THERE WERE A TOTAL OF 18 PROCEDURE-RELATED SERIOUS ADVERSE EVENTS INVOLVING 14 PATIENTS. REPORTED SERIOUS EVENTS INCLUDED: THROMBOCY TOPENIA (1), PNEUMONIA (1), APHASIA (1), BRAIN EDEMA (1), CEREBRAL HEMORRHAGE (2), INTRACRANIAL HEMORRHAGE (2), ISCHEMIC STROKE (3), MIGRAINE (1), HALLUCINATIONS (1), PULMONARY EMBOLISM (1), RESPIRATORY FAILURE (1), DEEP VEIN THROMBOSIS (1), VESSEL PERFORATION (2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704200 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Other| R