BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 17390361 · Received July 25, 2023

    Report

    Report Number
    2029214-2023-01172
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    August 25, 2018
    Report Date
    July 25, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT P ROVIDED IN THE PUBLISHED LITERATURE. SEE ATTACHED LITERATURE ARTICLE NO SPECIFIC DEVICE INFORMATION PROVIDED. 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

    ZHANG, B., FENG, X., PENG, F., WANG, L., GUO, E. K., ZHANG, Y., LIU, P., WU, Z., LIU, A. SEIZURE PREDICTORS AND OUTCOME AFTER ONYX EMBOLIZATION IN PATIENTS WITH BRAIN ARTERIOVENOUS MALFORMATIONS. INTERVENTIONAL NEURORADIOLOGY. 2019. VOL. 25(2) 124¿131. DOI:(B)(6). SUMMARY: BRAIN ARTERIOVENOUS MALFORMATION (BAVM)-RELATED EPILEPSY CAN SIGNIFICANTLY AFFECT PATIENT QUALITY OF LIFE. WE AIMED TO IDENTIFY THE FACTORS ASSOCIATED WITH SEIZURES OCCURRENCE AND EVALUATE THE LONG-TERM OUTCOME FOLLOWING ONYX EMBOLIZATION IN BAVM PATIENTS. METHODS: ON (B)(6), 2014 AND (B)(6), 239 CONSECUTIVE PATIENTS UNDERWENT TREATMENT FOR BAVMS IN OUR INSTITUTE AND WERE RESPECTIVELY ANALYZED. DEMOGRAPHICS, SEIZURE STATUS AND BAVM MORPHOLOGIC CHARACTERISTICS WERE RECORDED. MODIFIED ENGEL CLASSIFICATION WAS USED TO EVALUATE THE LONG-TERM SEIZURE OUTCOMES. RESULTS: OF 239 BAVM PATIENTS, 68 (28.5%) INITIALLY PRESENTED WITH SEIZURES. SEIZURE OCCURRENCE WAS ASSOCIATED WITH CEREBRAL HEMORRHAGE HISTORY, FRONTAL-TEMPORAL LOCATION AND ARTERIAL BORDERZONE LOCATION. OF THE 37 PATIENTS WHO PRESENTED WITH INITIAL SEIZURES AND WERE TREATED WITH ONYX EMBOLIZATION, 23 (62.2%) WERE TREATED WITH ANTIEPILEPTIC DRUGS (AEDS) BEFORE ONYX EMBOLIZATION. AT THE LAST FOLLOW-UP VISIT, 19 (51.4%) OF THE 37 PATIENTS REACHED MODIFIED ENGEL CLASS I OUTCOME. OF THE 23 PATIENTS WHO HAD EVER BEEN TREATED WITH AEDS, 12 (52.2%) WERE STILL TAKING AEDS AT THE LAST FOLLOW-UP VISIT. SINGLE-FACTOR ANALYSIS SHOWED THAT ARTERIAL BORDERZONE LOCATION WAS SIGNIFICANTLY CORRELATED WITH HIGHER MODIFIED ENGEL CLASS OUTCOME (P ¼ 0.046). CONCLUSION: PATIENTS WITH BAVM HEMORRHAGE HISTORY, FRONTAL-TEMPORAL LOCATION AND ARTERIAL BORDERZONE LOCATION WERE ASSOCIATED WITH SEIZURE OCCURRENCE. SEIZURE-FREE STATUS WAS NOT OBTAINED IN AVM PATIENTS WITH ARTERIAL BORDERZONE AFTER EMBOLIZATION, THOUGH IT M AY HAVE BENEFITS IN OTHER WAYS. THE SEIZURE-FREE MECHANISM OF BAVM WITH ONYX EMBOLIZATION IS WORTH FURTHER STUDY. REPORTED EVENTS: ONE PATIENT SUFFERED AVM RUPTURE ONE DAY AFTER EMBOLIZATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555483 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown