BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 21421319 · Received February 20, 2025

    Report

    Report Number
    2029214-2025-00463
    Event Type
    Injury
    Date Received
    February 20, 2025
    Date of Event
    December 28, 2024
    Report Date
    May 15, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID UNK-NV-SOLITAIRE (UNKNOWN); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID UNK-NV-ONYX (UNKNOWN); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID UNK-NV-SOLITAIRE (UNKNOWN); IMPLANT DATE N/A; EXPLANT DATE N/A G2: CITATION: AUTHORS: SARSHAYEV, M.; TURDALIYEVA, B.; TANBAYEVA, G.; MAKHANBETKHAN, S.; MUSSABEKOV, M.; DAVLETOV, D.; MAIDAN, A.; B ERDIKHOJAYEV, M.. DOI.ORG/ 10.3390/JCM14010125. J. CLIN. MED. 14, 125 2025. DOI: 10.3390/JCM14010125. 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. 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.

    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

    LITERATURE REVIEWED: STUDY TITLE: "DEMOGRAPHIC CHARACTERISTICS AND TREATMENT OUTCOMES OF INTRACRANIAL ATHEROSCLEROSIS STENTING: A RETROSPECTIVE CASE-SERIES OF 216 CONSECUTIVE PATIENTS." OBJECTIVE: TO ANALYZE DEMOGRAPHIC CHARACTERISTICS, TREATMENT OUTCOMES, AND PROCEDURAL CHALLENGES AS SOCIATED WITH INTRACRANIAL ATHEROSCLEROSIS (ICAS) IN PATIENTS TREATED AT A SINGLE INSTITUTION. STUDY TIME FRAME: FROM JANUARY 2016 TO DECEMBER 2023. MANUFACTURERS: MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION, INCLUDING PRODUCTS FROM TERUMO CORPORATION, MEDTRONIC INC., BOSTON SCIENTIFIC, MERIL LIFE SCIENCES, AND OTHERS. MEDTRONIC DEVICES USED: RESOLUTE INTEGRITY, ONYX (19 CASES) AND SOLITAIRE (2 CASES). DEATHS: DEATHS OCCURRED IN THE STUDY POPULATION. CAUSES OF DEATH: TWO DEATHS: ONE DUE TO ISCHEMIC COMPLICATIONS AND THE OTHER FROM INTRAVENTRICULAR TAMPONADE, A HEMORRHAGIC COMPLICATION. DURING THE 72-H PERIPROCEDURAL PERIOD FOLLOWING THE PROCEDURE, TWO DEATHS FROM STROKES WERE REPORTED, RESULTING IN A 0.7% PERIPROCEDURAL COMPLICATION RATE. THESE FATALITIES OCCURRED IN PATIENTS WITH BASELINE STENOSIS OF 90% OR GREATER IN THE LEFT VERTEBRAL ARTERY. ONE DEATH WAS ATTRIBUTED TO ISCHEMIC COMPLICATIONS, WHILE THE OTHER RESULTED FROM INTRAVENTRICULAR TAMPONADE, CLASSIFIED AS A HEMORRHAGIC COMPLICATION. ADVERSE EVENTS: THE PERIPROCEDURAL COMPLICATION RATE WAS 0.7%. ADVERSE EVENTS INCLUDED STENT MIGRATION, FAILURE TO DEPLOY DUE TO VESSEL TORTUOSITY, IMMEDIATE THROMBOSIS, AND WORSENING MRS SCORES. NO FURTHER INFORMATION PERTAINING TO MEDTRONIC PRODUCTS

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED NO MEDTRONIC PRODUCTS WERE USED IN THE CASES OF THE TWO PATEINT'S THAT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465458 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening SEE H11...