BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 17415133 · Received July 28, 2023

    Report

    Report Number
    2029214-2023-01217
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    February 9, 2023
    Report Date
    July 28, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: ALATZIDES, G. L., OPITZ, M., LI, Y., GOERICKE, S., OPPONG, M. D., FRANK, B., ECKSTEIN, A. K., KÖHRMANN, M., WREDE, K., FORSTING, M., WANKE, I., DEUSCHL, C.. MANAGEMENT OF CAROTID CAVERNOUS FISTULAS: A SINGLE CENTER EXPERIENCE. FRONTIERS IN NEUROLOGY 14:1123139 2023. DOI:10.3389/FNEUR.2023.1123139 A.2. THIS VALUE IS THE MEDIAN 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

    ALATZIDES GL, OPITZ M, LI Y, ET AL. MANAGEMENT OF CAROTID CAVERNOUS FISTULAS: A SINGLE CENTER EXPERIENCE. FRONTIERS IN NEUROLOGY. 20 23;14:1123139. 10.3389/FNEUR.2023.1123139 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH ONYX. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE ENDOVASCULAR THERAPY (EVT) OF CAROTID CAVERNOUS FISTULA (CCF) WITH DIFFERENT NEUROENDOVASCULAR TECHNIQUES REGARDING OCCLUSION RATES, COMPLICATIONS AND OUTCOMES. FROM 2001 TO 2021, 59 PATIENTS WERE ENROLLED FOR THIS RETROSPECTIVE STUDY. AMONG THEM, 17 WERE MALES AND 42 FEMALES. MEDIAN AGE OF THE STUDY COHORT WAS 71.0 YEARS. EXCLUSIVELY COILS WERE USED IN 27/59, A COMBINATION OF ETHYLENE VINYL ALCOHOL (EVOH) COPOLYMER (ONYX) AND COILS IN 25/59. IN FIVE PATIENTS, LIQUID EMBOLIZATION AGENTS WAS USED SOLELY AND IN TWO CASES A PERMANENT STENT GRAFT (LEO STENT, BALT, MONTMORENCY, FRANCE AND JOMED MASTERGRAFT, JOMED INTERNATIONAL, HELSINGBORG, SWEDEN) WAS IMPLANTED. IN 15 CASES A TEMPORARY ASSIST DEVICE FOR PROTECTION OF THE ICA WAS BROUGHT IN. THE ARTICLE STATES THE FOLLOWING TECHNICAL ISSUES DURING USE OF THE ONYX. -EXTRAVASATION OF LIQUID EMBOLIC THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: -IN 15/59 MORE THAN ONE SESSION WAS NECESSARY FOR ADEQUATE FISTULA OCCLUSION. -EMERGENCY SACRIFICE OF THE PARENT ARTERY, COMPLETE ICA OCCLUSION (3/59). -FOUR PATIENTS SHOWED A STABLE OR UNDULATING COURSE WITH OVERALL MINOR IMPROVEMENTS. -THREE PATIENTS REMAINED WITH A RESIDUAL ABDUCENS NERVE PALSY -ANOTHER PATIENT SHOWED PERSISTENT ELEVATED INTRAOCULAR PRESSURE AND A CILIARY INJECTION, ALTHOUGH A COMPLETE ENDOVASCULAR FISTULA OCCLUSION WAS ACHIEVED. -IN TWO CASES A PARTIAL OBLITERATION WITH MINOR RESIDUAL FLOW THROUGH THE FISTULA WAS SEEN IN THE IMMEDIATE POSTINTERVENTIONAL ANGIOGRAPHY. -7 CASES OF PARTIAL OBLITERATION WITH MINIMAL RESIDUAL FISTULA INFLOW AFTER POST-INTERVENTIONAL CROSS SECTIONAL IMAGING -EXTRAVASATION OF LIQUID EMBOLIC RESULTING IN THROMBOSIS OF THE SUPERIOR OPHTHALMIC VEIN WITH CONSECUTIVE OCULAR SYMPTOMATOLOGY; MASSIVE PROTRUSION OF THE OCULAR BULBI -DISSECTION OF THE ICA  -INTRAPROCEDURAL M1-OCCLUSION -INTRAPROCEDURAL  M2 OCCLUSION WITH ONLY PARTIAL RECANALIZATION AFTER APPLICATION OF ABCIXIMAB AND ALTEPLASE -INCOMPLETE FISTULA OCCLUSION -SPASM -INFARCTION -PULMONARY ARTERY EMBOLISM -INTRAPROCEDURAL CARDIAC ARREST WITH IMMEDIATE INTERRUPTION AFTER ATROPINE APPLICATION (NOPOSTINTERVENTIAL RESIDUUM -POST OP ACTIVE FEMORAL BLEEDING REQUIRING TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2328035 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Life Threatening| R