BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 17288777 · Received July 10, 2023

    Report

    Report Number
    2029214-2023-01056
    Event Type
    Injury
    Date Received
    July 10, 2023
    Date of Event
    July 20, 2022
    Report Date
    August 9, 2023
    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

    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.

    Additional Manufacturer Narrative · 0

    A2. REPORTED PATIENT AGE (50 YEARS) REPRESENTS THE MEAN AGE OF ALL PATIENTS INCLUDED IN THE LITERATURE ARTICLE STUDY. A3. REPORTED PATIENT SEX (FEMALE) IS REPRESENTATIVE OF THE MAJORITY OF PATIENTS INCLUDED IN THE LITERATURE ARTICLE STUDY. 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

    ADDITIONAL INFORMATION RECEIVED REPORTED NONE OF THE ADVERSE EVENTS IN THE ARTICLE WERE DIRECTLY RELATED TO MEDTRONIC DEVICES OR PRODUCTS.

    Description of Event or Problem · 0

    LIU, P., LIU, Y., SHI, Y., AN, Q., ZHU, W., LIU, Y., LI, P., TIAN, Y. (2022). THE VASCULAR ARCHITECTURE OF CAVERNOUS SINUS DURAL ARTERIOVENOUS FISTULA AND ITS IMPACT ON ENDOVASCULAR TREATMENT APPROACH SELECTION AND OUTCOME. WORLD NEUROSURGERY, 166, E770¿E780. HTTPS://DOI.ORG/10.1016/J.WNEU.2022.07.094. MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND A RETROSPECTIVE ANALYSIS OF CLINICAL DATA FROM 64 PATIENTS WHO UNDERWENT SURGICAL EMBOLIZATION TREATMENT OF CAVERNOUS SINUS (CS) DURAL ARTERIOVENOUS FISTULA (DAVF). 14 PATIENTS WERE TREATED ONLY WITH ONYX, 40 PATIENTS WERE TREATED WITH COILS + ONYX, AND 10 PATIENTS WERE TREATED WITH COILS ONLY. THERE WERE NO REPORTED DEVICE ISSUES IN THE ARTICLE. IT WAS NOTED THAT 9 PATIENTS HAD INCOMPLETE EMBOLIZATION IN THE INDEX PROCEDURE, 8 OF THESE PATIENTS WERE TREATED WITH ONYX OR ONYX + COILS. NO ADDITIONAL TREATMENT OR OTHER ASSOCIATED COMPLICATIONS WERE NOTED ASSOCIATED WITH THE INCOMPLETE EMBOLIZATIONS. DURING FOLLOW-UP WHICH RANGED FROM 2 TO 123 MONTHS FOR 76.6% OF PATIENTS, 6 PATIENTS HAD A MODIFIED RANKIN SCORE (MRS) OF 3-5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693364 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other| S