BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX

    MDR report key: 20517369 · Received October 23, 2024

    Report

    Report Number
    2029214-2024-01964
    Event Type
    Death
    Date Received
    October 23, 2024
    Date of Event
    November 30, 2022
    Report Date
    October 23, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    PACINI, A., SHOTAR, E., GRANGER, B., MAIZEROI-EUGÈNE, F., DELAITRE, M., TALBI, A., BOCH, A.-L., VALÉRY, C.-A., PREMAT, K., DRIR, M., LENCK, S., MOUNAYER, C., SOUROUR, N.-A., <(>&<)> CLARENÇON, F.; JOURNAL OF NEUROINTERVENTIONAL SURGERY; 2023; 15(10), 1095-1103; NIDUS COMPACITY DETERMINED BY SEMI-AUTOMATED SEGMENTATION IS A STRONG QUANTITATIVE PREDICTOR OF BRAIN ARTERIO-VENOUS MALFORMATION CURE; DOI.ORG/10.1007/S00062-023-01313. LITERATURE WAS REVIEWED REGARDING: "NIDUS COMPACITY DETERMINED BY SEMI-AUTOMATED SEGMENTATION IS A STRONG QUANTITATIVE PREDICTOR OF BRAIN ARTERIO-VENOUS MALFORMATION CURE." THE TIME FRAME OF THIS STUDY WAS: 2003 TO 2018. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: ETHYLENE VINYL ALCOHOL (EVOH; ONYX 18, MEDTRONIC, IRVINE, CA). DEATHS OCCURRED IN THE STUDY POPULATION. THE CAUSES OF DEATH WERE: 3 PATIENTS (7%) IN THE RUPTURED GROUP DIED AT THE ACUTE PHASE DUE TO THE INITIAL INTRA-CEREBRAL HEMORRHAGE (ICH). 4 PATIENTS (8%) INTHE UNRUPTURED GROUP: 2 PATIENTS DIED FROM ANOTHER PATHOLOGY NOT RELATED TO THE BAVM, 1 DIED FROM SPONTANEOUS ICH (WITHOUT ANY PREVIOUS EXCLUSION TREATMENT), AND 1 DIED FROM AN EARLY COMPLICATION POST-EMBOLIZATION (SEVERE ICH). AMONG PATIENT ADVERSE EVENTS INCLUDED: ISCHEMIC COMPLICATIONS (79%). ISCHEMIC COMPLICATIONS WERE DEFINED AS HYPODENSITY SYSTEMATIZED TO A VASCULAR TERRITORY VISIBLE MORE THAN 48 HOURS AFTER THE PROCEDURE OR BY HYPERINTENSITY ON DIFFUSION-WEIGHTED MRI WITH RESTRICTED ADC. HEMORRHAGIC COMPLICATIONS (21%). HEMORRHAGIC COMPLICATIONS WERE DEPICTED ON POST-PROCEDURE CT-SCAN OR BRAIN MRI. MAJOR COMPLICATIONS (5%): DEATH OR A PERMANENT SIGNIFICANT NEUROLOGICAL DEFICIT (MRS > 2) MINOR COMPLICATIONS (13%): TRANSIENT AND/OR MINOR NEUROLOGICAL DEFICIT (MRS <(><<)>3) THE OBLITERATION RATE FOR EMBOLIZATION ALONE WAS 62% (18/29 PATIENTS). NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425610 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Death| D