BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 20465536 · Received October 16, 2024

    Report

    Report Number
    2029214-2024-01902
    Event Type
    Injury
    Date Received
    October 16, 2024
    Date of Event
    January 6, 2023
    Report Date
    October 16, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: LI, J., JI, Z., YU, J., REN, J., YANG, F., BIAN, L., ZHI, X., LI, G., & ZHANG, H. ANGIOARCHITECTURE AND PROGNOSIS OF PEDIATRIC INTRACRANIAL PIAL ARTERIOVENOUS FISTULA. STROKE AND VASCULAR NEUROLOGY 8 (4), 292¿300 2023. DOI:10.1136/SVN-2022-001979 A.2. THIS VALUE IS THE MEAN AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE SEX OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING 'ANGIOARCHITECTURE AND PROGNOSIS OF PEDIATRIC INTRACRANIAL PIAL ARTERIOVENOUS FISTULA'. THE TIME FRAME OF THIS STUDY WAS (B)(6) 2010 TO (B)(6) 2019. CLINICAL DATA OF CONSECUTIVE (B)(4) PEDIATRIC PIAL ARTERIOVENOUS FISTULAS (PAVFS) WERE DOCUMENTED AND ANALYZED. THEIR MEAN AGE WAS 4.0 YEARS AND THE MAJORITY OF PATIENTS WERE MALE (26). MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: ONYX NO DEATHS WERE NOTED IN THE STUDY POPULATION. AMONG PATIENT ADVERSE EVENTS INCLUDED: -THE CURE RATES OF COIL COMBINED WITH GLUBRAN OR ONYX EMBOLIZATION WAS (B)(4) -THE INCIDENCE OF PROCEDURE-RELATED COMPLICATIONS WAS (B)(4), INCLUDING POSTOPERATIVE DRAINING VEIN THROMBOSIS ((B)(4) CASES), POSTOPERATIVE HEMORRHAGE ((B)(4) CASE) AND POSTOPERATIVE HEMIANOPIA OF THE BILATERAL VISUAL FIELD ((B)(4) CASE). PATIENTS SUFFERING FROM DRAINING VEIN THROMBOSIS PRESENTED WITH HEADACHE, NAUSEA AND VOMITING FOLLOWED BY GRAND MAL SEIZURES AND RECOVERED AFTER HEPARIN ANTICOAGULANT THERAPY. THE PATIENT SUFFERING FROM POSTOPERATIVE HEMORRHAGE PRESENTED WITH ONLY SLIGHT HEADACHE AND RECOVERED AFTER CONSERVATIVE TREATMENT. AND THE PATIENT SUFFERING FROM HEMIANOPIA OF THE BILATERAL VISUAL FIELD, CAUSED BY UNEXPECTED ARTERIAL EMBOLISM, ALMOST RECOVERED 1 YEAR LATER. -IN THE FOLLOW-UP ANGIOGRAPHY, DE NOVO DURAL ARTERIOVENOUS FISTULAS (DAVFS) WITH CORTICAL VEINS INVOLVED (CLASSIFICATION WAS COGNARD IIB AND BORDEN II) WERE FOUND IN (B)(4). NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202151 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Required Intervention