BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 17483825 · Received August 8, 2023

    Report

    Report Number
    2029214-2023-01320
    Event Type
    Injury
    Date Received
    August 8, 2023
    Date of Event
    June 9, 2023
    Report Date
    August 8, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: BAH, M. G., WILSECK, Z. M., LIN, L. Y., CHAUDHARY, N., & GEMMETE, J. J.. SUCCESSFUL RETRIEVAL OF ETHYLENE VINYL ALCOHOL (EVOH) FROM THE LEFT MIDDLE CEREBRAL ARTERY DURING PREOPERATIVE EMBOLIZATION OF A JUVENILE NASOPHARYNGEAL ANGIOFIBROMA (JNA). INTERVENTIONAL NEURORADIOLOGY: JOURNAL OF PERITHERAPEUTIC N JUNE 2023:15910199231184512 2023. DOI:10.1177/15910199231184511. 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

    BAH MG, WILSECK ZM, LIN LY, CHAUDHARY N, GEMMETE JJ. SUCCESSFUL RETRIEVAL OF ETHYLENE VINYL ALCOHOL (EVOH) FROM THE LEFT MIDDLE CEREBRAL ARTERY DURING PREOPERATIVE EMBOLIZATION OF A JUVENILE NASOPHARYNGEAL ANGIOFIBROMA (JNA). INTERVENTIONAL NEURORADIOLOGY: JOURNAL OF PERITHERAPEUTIC NEURORADIOLOGY, SURGICAL PROCEDURES AND RELATED NEUROSCIENCES. JUNE 2023:15910199231184512. DOI:10.1177/15910199 231184511. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH ONYX LIQUID EMBOLIC. THE PURPOSE OF THIS ARTICLE WAS TO PRESENT A UNIQUE CASE INVOLVING THE MIGRATION OF ONYX ETHYL VINYL ALCOHOL (EVOH) INTO THE LEFT MIDDLE CEREBRAL ARTERY (MCA) THROUGH AN EXTERNAL CAROTID ARTERY¿INTERNAL CAROTID ARTERY (ECA¿ICA) COLLATERAL DURING PREOPERATIVE EMBOLIZATION USING A DUAL-LUMEN BALLOON CATHETER. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED:  - DURING THE EMBOLIZATION PROCEDURE, A SMALL PORTION OF THE ONYX CAST MIGRATED INTO THE INTRACRANIAL CIRCULATION THROUGH A HYPERTROPHIED ECA¿ICA COLLATERAL. ANGIOGRAPHY CONFIRMED EMBOLIC MATERIAL AT THE LEFT MCA BIFURCATION. THE DECISION WAS MADE TO WAIT FOR THE DMSO TO DISSIPATE, ALLOWING THE ONYX TO HARDEN PRIOR TO ATTEMPTING REMOVAL, POSSIBLY REDUCING RISK OF FRAGMENTATION. CONTINUOUS INTRAOPERATIVE NEUROMONITORING REMAINED STABLE THROUGHOUT THE PROCEDURE. ATTENTION WAS THEN TURNED TO EMBOLIZATION OF THE LEFT ACCESSORY MIDDLE MENINGEAL ARTERY WITH ONYX USING AN ADDITIONAL DUAL-LUMEN BALLOON CATHETER. THIS RESULTED IN NEAR COMPLETE DEVASCULARIZATION OF THE TUMOR. REPEAT ICA ANGIOGRAM SHOWED A PERSISTENT PARTIALLY OCCLUSIVE FILLING DEFECT AT THE LEFT MCA BIFURCATION WITH PATENCY OF THE DISTAL MCA CANDELABRA. THE EMBOLIC MATERIAL WAS THEN SUCCESSFULLY REMOVED USING A BALLOON GUIDE CATHETER AND STENTRIEVER. REPEAT LEFT ICA ANGIOGRAPHY DEMONSTRATED A WIDELY PATENT MCA WITHOUT DISTAL SLOW FLOW OR EVIDENCE OF DISTAL EMBOLI. POST-EMBOLIZATION LEFT COMMON CAROTID ANGIOGRAM SHOWED GREATER THAN 95% DEVASCULARIZATION OF THE TUMOR. FOLLOWING THE PROCEDURE, THE PATIENT MADE A FULL RECOVERY FROM THE ANESTHETIC, WAS EXTUBATED, AND EMERGED NEUROLOGICALLY INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344812 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male Required Intervention