BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 17281889 · Received July 7, 2023

    Report

    Report Number
    2029214-2023-01047
    Event Type
    Injury
    Date Received
    July 7, 2023
    Date of Event
    April 4, 2023
    Report Date
    July 7, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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. 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

    MINICI, R., VENTURINI, M., FONTANA, F., GUZZARDI, G., PINGITORE, A., PIACENTINO, F., SERRA, R., COPPOLA, A., SANTORO, R., LAGANA, D. EFFICACY AND SAFETY OF ETHYLENE-VINYL ALCOHOL (EVOH) COPOLYMER-BASED NON-ADHESIVE LIQUID EMBOLIC AGENTS (NALEAS) IN TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) OF ACUTE NON-NEUROVASCULAR BLEEDING: A MULTICENTER RETROSPECTIVE COHORT STUDY. Y. MEDICINA. 2023. 59, 710. DOI: 10.3390/ MEDICINA59040710 SUMMARY: BACKGROUND AND OBJECTIVES: TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) IS PART OF THE DAILY PRACTICE OF MOST INTERVENTIONAL RADIOLOGISTS WORLDWIDE. THE IDEAL LIQUID EMBOLIC AGENT IS FAR FROM BEING IDENTIFIED. NON-ADHESIVE LIQUID EMBOLIC AGENTS (NALEA) HARDEN FROM THE OUTSIDE TO THE INSIDE, RESULTING IN DEEP PENETRATION, KNOWN AS ¿MAGMA-LIKE¿ PROGRESSION, WHICH PERMITS A MORE DISTAL EMBOLIZATION WITH GOOD CONTROL OF THE EMBOLIC MATERIAL. THIS MULTICENTER RETROSPECTIVE COHORT STUDY AIMS TO ASSESS THE EFFICACY, FEASIBILITY AND SAFETY OF TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) WITH ETHYLENE-VINYL ALCOHOL (EVOH)-BASED NALEAS (ONYX AND SQUID) IN ACUTE BLEEDING OUTSIDE OF THE NEUROVASCULAR AREA. MATERIALS AND METHODS: THIS STUDY IS A MULTICENTER ANALYSIS OF RETROSPECTIVELY COLLECTED DATA OF CONSECUTIVE PATIENTS WHO HAD UNDERGONE, FROM JANUARY 2015 TO DECEMBER 2022, TRANSCATHETER ARTERIAL EMBOLIZATION WITH NON-ADHESIVE EVOH-BASED AGENTS IN THE SETTING OF ACUTE NONNEUROVASCULAR BLEEDING. RESULTS: FIFTY-THREE PATIENTS UNDERWENT TRANSCATHETER ARTERIAL EMBOLIZATION FOR ACUTE NON-NEUROVASCULAR BLEEDING. EIGHT (15.1%) PROCEDURES WERE PERFORMED IN PATIENTS WITH COAGULOPATHY. THE MOST USED CONCENTRATION OF EVOH-BASED NALEAS WAS 34 (I.E., 8%), WITH A MEAN DOSE OF 0.5 (±0.3) ML. THE MEAN CT-TO-GROIN TIME, THE MEAN PROCEDURE TIME, THE MEAN CT-TO-EMBOLIZATION TIME AND THE MEAN FLUOROSCOPY TIME WERE 22.9 (±12.4) MIN, 27.5 (±7) MIN, 50.3 (±13.1) MIN AND 7.5 (±2.8) MIN, RESPECTIVELY. TECHNICAL SUCCESS WAS ACHIEVED IN ALL CASES WITH A 96.2% CLINICAL SUCCESS RATE. COMPLICATIONS WERE RECORDED IN SIX (11.3%) PATIENTS. NO STATISTICALLY SIGNIFICANT DIFFERENCES WERE OBSERVED BETWEEN THE GROUP OF PATIENTS WITH COAGULOPATHY AND THE GROUP OF PATIENTS WITHOUT COAGULOPATHY IN TERMS OF EFFICACY AND SAFETY ENDPOINTS. CONCLUSIONS: TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) PERFORMED WITH NON-ADHESIVE EVOH-BASED EMBOLIC AGENTS IS AN EFFECTIVE, FEASIBLE AND SAFE STRATEGY FOR THE MANAGEMENT OF ACUTE NON-NEUROVASCULAR BLEEDING, EVEN IN THE SUBGROUP OF PATIENTS WITH COAGULOPATHY REPORTED EVENTS: ONE CASE OF NONTARGET EMBOLIZATION WAS OBSERVED AND WITH NO CLINICAL CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612632 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown