BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 20444807 · Received October 14, 2024

    Report

    Report Number
    2029214-2024-01865
    Event Type
    Injury
    Date Received
    October 14, 2024
    Date of Event
    July 26, 2023
    Report Date
    April 23, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: UNK-NV-MARATHON (UNKNOWN); G2: CITATION: AUTHORS: BORGES DE ALMEIDA, G., PAMPLONA, J., BAPTISTA, M., CARVALHO, R., CONCEIÇÃO, C., LOPES DA SILVA, R., SAGARRIBAY, A., REIS, J., FRAGATA, I. ENDOVASCULAR TREATMENT OF BRAIN ARTERIOVENOUS MALFORMATIONS IN PEDIATRIC PATIENTS: A SINGLE CENTER EXPERIENCE AND REVIEW OF THE LITERATURE. JOURNAL OF NEUROLOGICAL SURGERY PART A, CENTRAL EUROPEAN NS 85(4), 361¿370 2024. DOI:1 0.1055/S-0043-1770356. 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

    MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF SMALL OCCIPITAL ISCHEMIC LESION IN ASSOCIATION WITH ONYX EMBOLIZATION WITH USE OF THE MARATHON CATHETER. THE TIME FRAME OF THIS STUDY WAS FROM JANUARY 2010 TO JUNE 2021. THE PURPOSE OF THIS ARTICLE WAS TO ASSESS THE EFFECTIVENESS AND SAFETY OF ENDOVASCULAR TREATMENT IN THIS PATIENT POPULATION AND TO EVALUATE THE OUTCOMES OF THE TREATMENT, INCLUDING THE NEED FOR ADJUVANT THERAPY AND FOLLOW-UP RESULTS. THE AUTHORS REVIEWED 2 CASES OF PEDIATRIC PATIENTS TREATED FOR ARTERIOVENOUS MALFORMATION USING ONYX. THERE WERE A TOTAL OF 12 PATIENTS IN THIS STUDY, THE REMAINING 10 PATIENTS WERE TREATED WITH NBCA. OF THE 2 PATIENTS, THE AVERAGE AGE WAS 14 YEARS, 1 WAS FEMALE AND 1 WAS MALE. THE STUDY SUPPORTS THE EFFECTIVENESS AND SAFETY OF ENDOVASCULAR TREATMENT OF BAVM IN SELECTED PEDIATRIC PATIENTS. A MULTIDISCIPLINARY APPROACH COMBINING SURGERY AND SRS IS WARRANTED TO ACHIEVE HIGHER COMPLETE BAVM OBLITERATION RATES. LONG-TERM FOLLOW-UP IS IMPORTANT AS THESE LESIONS MAY SHOW RECURRENCE OVER TIME, ESPECIALLY IN THE PEDIATRIC POPULATION. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE ONYX OR THE MARATHON CATHETER. IN ADDITION, THE ONE PATIENT'S MRS SCORE AT 6 MONTHS WAS 1 AND THE OTHER WAS A SCORE OF 2. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: SMALL OCCIPITAL ISCHEMIC LESION WITH SUBSEQUENT HOMONYMOUS HEMIANOPIA IN 1 PATIENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED NONE OF THE ADVERSE EFFECTS HIGHLIGHTED IN THE PAPER OCCURRED BECAUSE OF ISSUES WITH MEDTRONIC PRODUCTS. SIDE EFFECTS HAVE OCCURRED BECAUSE OF OTHER TECHNIQUE-RELATED ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1873947 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other