BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 17308287 · Received July 12, 2023

    Report

    Report Number
    2029214-2023-01097
    Event Type
    Injury
    Date Received
    July 12, 2023
    Date of Event
    December 6, 2021
    Report Date
    July 12, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: CATAPANO, J. S., DUCRUET, A. F., SRINIVASAN, V. M., RUMALLA, K., NGUYEN, C. L., RUTLEDGE, C., COLE, T. S., BARANOSKI, J. F., LAWTON, M. T., JADHAV, A. P.,ALBUQUERQUE, F. C.. RADIOGRAPHIC CLEARANCE OF CHRONIC SUBDURAL HEMATOMAS AFTER MIDDLE MENINGEAL ARTERY EMBOLIZATION. JOURNAL OF NEUROINTERVENTIONAL SURGERY 14(12):1279-1283 2022. DOI:10.1136/NEURINTSURG-2021-018073 A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER 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 IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    CATAPANO JS, DUCRUET AF, SRINIVASAN VM, ET AL. RADIOGRAPHIC CLEARANCE OF CHRONIC SUBDURAL HEMATOMAS AFTER MIDDLE MENINGEAL ARTERY EMBOLIZATION. JOURNAL OF NEUROINTERVENTIONAL SURGERY. 2022;14(12):1279-1283. DOI:10.1136/NEURINTSURG-2021-018073 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH ONYX. THE PURPOSE OF THIS ARTICLE WAS TO ANALYZE RADIOGRAPHIC EVIDENCE OF CHRONIC SUBDURAL HEMATOMA (CSDH) CLEARANCE AFTER MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION TO ELUCIDATE OPTIMAL TECHNIQUES, HEMATOMA CLEARANCE RATES, AND SUITABLE LENGTH OF FOLLOW-UP. PATIENTS WHO UNDERWENT MMA EMBOLIZATION FOR CSDH FROM JANUARY 1, 2018 THROUGH DECEMBER 31, 2020 WERE ANALYZED. THE STUDY COHORT COMPRISED 66 PATIENTS WITH 84 TREATED CSDHS. THE MEAN PATIENT AGE WAS 70 YEARS; 51 PATIENTS WERE MEN, AND 15 WERE WOMEN. OF THE 84 CSDHS TREATED, RADIAL ARTERY ACCESS WAS USED FOR 65, AND 66 CSDHS WERE EMBOLIZED USING A LIQUID EMBOLIC AGENT (ONYX). OF THE 84 CSDHS TREATED, BOTH ANTERIOR AND POSTERIOR BRANCHES WERE EMBOLIZED IN 61, AND DISTAL EMBOLIZATION WAS ACHIEVED IN 57 HEMORRHAGES. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE ONYX. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: -A GREATER PERCENTAGE OF CSDHS HAD COMPLETE OR NEAR-COMPLETE RESOLUTION AT THE 180-DAY POST-EMBOLIZATION FOLLOW-UP (92%, 67/73) THAN AT THE 90-DAY (63%, 45/72) AND 30-DAY (18%, 15/84) FOLLOW-UP. SURGICAL RESCUE WAS REQUIRED AFTER THREE CSDH TREATMENTS. IN THESE THREE PATIENTS WHO REQUIRED SURGICAL RESCUE, EACH CSDH OCCURRED BEFORE THE 30-DAY FOLLOW-UP AND THESE PATIENTS¿ CSDHS WERE CATEGORIZED AS ¿NO RESOLUTION¿ ON EACH FOLLOW-UP DATE ANALYZED -ONE PATIENT WHO UNDERWENT COMBINED SUBDURAL DRAIN PLACEMENT AND MMA EMBOLIZATION EXPERIENCED AN ACUTE HEMORRHAGE DUE TO INADVERTENT PROXIMAL FLUSHING INTO THE SUBDURAL SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748311 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention