BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 17278249 · Received July 7, 2023

    Report

    Report Number
    2029214-2023-01043
    Event Type
    Injury
    Date Received
    July 7, 2023
    Date of Event
    July 18, 2022
    Report Date
    July 7, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. 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

    PFEIFER, J., WOHLGEMUTH, W. A., ABDUL-KHALIQ, H. LIQUID EMBOLIZATION OF PERIPHERAL ARTERIOVENOUS MALFORMATIONS WITH ETHYLENE-VINYL ALCOHOL COPOLYMER IN NEONATES AND INFANTS. 2022. VOLUME 2022, ARTICLE ID 1022729, 8 PAGES. DOI: 10.1155/2022/1022729 SUMMARY: IN THE POSTNATAL PERIOD, EXTENSIVE PERIPHERAL ARTERIOVENOUS MALFORMATIONS (AVM) ARE ASSOCIATED WITH HIGH MORBIDITY, ESPECIALLY WHEN LOCALIZED IN THE LIVER. THEIR URGENT TREATMENT IS ALWAYS A CHALLENGING PROBLEM IN NEONATES AND INFANTS. WE ANALYZED FOUR CONSECUTIVE CHILDREN AGED THREE DAYS TO THREE YEARS WHO UNDERWENT EIGHT LIQUID EMBOLIZATION PROCEDURES WITH ETHYLENE-VINYL ALCOHOL COPOLYMER. THE AVM WERE SITUATED ON THE THORACIC WALL, IN THE LIVER, AND ON THE LOWER LEG. IN THREE CASES, THE MALFORMATIONS SHOWED TOTAL REGRESSION. THE TIBIAL AVM DEGENERATED WIDELY. IF IMPAIRED BEFOREHAND, CARDIAC OR HEPATIC FUNCTION NORMALIZED AFTER THE INTERVENTIONS. THERE WERE NO EMBOLIZATION-ASSOCIATED COMPLICATIONS SUCH AS NONTARGET EMBOLIZATION OR TISSUE ISCHEMIA. WE CONCLUDE THAT APPLICATION OF ETHYLENE-VINYL ALCOHOL COPOLYMER SEEMS TO BE A SAFE THERAPEUTIC OPTION AND CAN BE USED IN NEONATES AND INFANTS WITH PERIPHERAL AVM IN CONSIDERATION OF THE AGENT¿S CHARACTERISTICS. NEVERTHELESS, THERE ARE STILL HARDLY ANY DATA CONCERNING YOUNG CHILDREN. REPORTED EVENTS: AS A SIDE EFFECT IN ALL PATIENTS, THERE WAS AN UNCOMFORTABLE SMELL REGRESSING WITHIN ABOUT 48 HOURS, TYPICALLY CAUSED BY THE SULFUR- CONTAINING DMSO. IN PATIENT 4, THERE WAS A SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS) WITH HYPOTENSION AND INCREASED SHOCK PARAMETERS, ACIDOSIS, AND COAGULOPATHY AFTER THE FIRST PROCEDURE. AT THE TIME OF THE PROCEDURE, THE NEWBORN WAS ALREADY IN VERY UNSTABLE HEMODYNAMIC CONDITIONS DUE TO THE HIGHOUTPUT CARDIAC FAILURE AND SUPRASYSTEMIC PULMONARY HYPERTENSION. WITHIN ONE YEAR AFTER THE EMBOLIZATION, ALL LIVER PARAMETERS WERE NORMALIZED. SEVERAL FOLLOW-UP STUDIES BY COLOR DOPPLER REVEALED NO REVASCULARIZATION OF THE HEPATIC AVM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055249 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention