BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX

    MDR report key: 20637587 · Received November 8, 2024

    Report

    Report Number
    2029214-2024-02094
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    July 7, 2023
    Report Date
    November 7, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: UNK-NV-ONYX (UNKNOWN); IMPLANT DATE: N/A; EXPLANT DATE: N/A. G2: CITATION: AUTHORS: DEVARAJAN A, SCHUPPER A, ROSSITTO C, BONET J, SORSCHER M, VASAN V, MORGENSTERN, GHATANS, SHIGEMATSU T, BERENSTEIN A, FIFI J. USE OF A MINI BALLOON MICROCATHETER TO FACILITATE PENETRATION OF FINE VASCULAR NETWORKS AND CURATIVE EMBOLIZATION IN VEIN OF GALEN MALFORMATIONS. JOURNAL OF NEUROINTERVENTIONAL SURGERY 0:1¿9 2023. 10.1136/JNIS-2023-020577. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE USE OF A MINI BALLOON MICROCATHETER TO FACILITATE PENETRATION OF FINE VASCULAR NETWORKS AND CU RATIVE EMBOLIZATION IN VEIN OF GALEN MALFORMATIONS. THE TIME FRAME OF THIS STUDY WAS FROM MAY 11, 2023, TO JULY 7, 2023. THE MEDTRONIC DEVICE USED WAS ONYX-18. EMBOLIZATION WITH ONYX-18 AND SIGNIFICANT NETWORK PENETRATION OCCURRED IN 17/17 USES. NO DEATHS OCCURRED IN THE STUDY POPULATION. AMONG PATIENT ADVERSE EVENTS INCLUDED: NEAR TIP ENTRAPMENT WITH LEA CAST DISPLACEMENT OCCURRED IN 1/17 USES. ANOTHER PATIENT EXPERIENCED POSTPROCEDURAL INTRAVENTRICULAR HEMORRHAGE REQUIRING A THIRD VENTRICULOSTOMY WITHOUT PERMANENT NEUROLOGIC DEFICIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877032 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Unknown