BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 17385823 · Received July 24, 2023

    Report

    Report Number
    2029214-2023-01165
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    December 30, 2022
    Report Date
    July 24, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    MOHAMED SHEHABELDIN, ABDELAZIZ AMLLAY, ROLAND JABRE, CHING-JEN CHEN, VICTORIA SCHUNEMANN, NABEEL A. HERIAL, M. REID GOOCH, LARAMI MACKENZIE, HANA CHOE, STAVROPOULA TJOUMAKARIS, ROBERT H. ROSENWASSER; NEUROSURGERY; 2023; 92:979¿985; ONYX VERSUS PARTICLES FOR MIDDLE MENINGEAL ARTERY EMBOLIZATION IN CHRONIC SUBDURAL HEMATOMA; DOI.ORG/10.1227/NEU.0000000000002307. MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE OF PATIENTS TREATED WITH ONYX HAVING COMPLICATIONS. THE PURPOSE OF THE ARTICLE WAS TO COMPARE BETWEEN 2 DIFFERENT EMBOLIC AGENTS; ONYX (ETHYLENE VINYL ALCOHOL) AND EMBOPARTICLES (POLYVINYL ALCOHOL PARTICLES¿PVA) FOR ENDOVASCULAR TREATMENT OF CHRONIC SUBDURAL HEMATOMA (CSDH). AMONG THESE INCLUDED EMBOLIZATIONS, 49 RECEIVED ONYX. 13 WERE FEMAL. THE MEAN AGE WAS 72 YEARS.  PROCEDURE: ALL ONYX PROCEDURES WERE PERFORMED UNDER GENERAL ANESTHESIA OR MONITORED ANESTHESIA CARE IN CONJUNCTION WITH INTRA-ARTERIAL LIDOCAINE ADMINISTRATION BEFORE DIMETHYL-SULFOXIDE (DMSO) INJECTION. TREATMENT STRATEGY INCLUDING THE CHOICE OF EMBOLIZING AGENT AND APPROACH WAS LEFT TO THE DISCRETION OF THE ENDOVASCULAR NEUROSURGEON OR INTERVENTIONAL NEUROLOGIST PERFORMING THE TREATMENT. GENERALLY, A 6 TO 7 FRENCH FEMORAL OR RADIAL SHEATH IS OBTAINED, A GUIDE CATHETER: BENCHMARK, RIST, OR ENVOY, AND A SELECTION CATHETER IS NAVIGATED OVER A 035 OR 0.038 GUIDEWIRE TO THE MAIN EXTERNAL CAROTID ARTERY TRUNK, A DMSO COMPATIBLE MICROCATHETER: ECHELON 10, HEADWAY, MARATHON, OR APOLLO GUIDED BY 0.014 OR 0.010 MICROWIRE IS NAVIGATED TO THE MIDDLE MENINGEAL ARTERY (MMA). A MICROINJECTION OF THE MMA IS OBTAINED TO ASSESS ANATOMY, ENSURE ADEQUATE MICROCATHETER POSITIONING, AND CONFIRM THE MICROCATHETER DISTAL TO THE PETROSQUAMOSAL BRANCH, RULE OUT CONTRAST EXTRAVASATION OR COLLATERALS TO THE RETINA OR OTHER DANGEROUS ANASTOMOSIS. FRONTAL, PARIETAL, OR BOTH MMA BRANCHES WERE SELECTIVELY CATHETERIZED WITH INTENTION OF EMBOLIZATION BASED ON ANATOMY. ONYX 18 PRECEDED BY DMSO OR EMBOPARTICLES/EMBOSPHERES100 TO 300 M MIXED WITH CONTRAST IS INJECTED UNDER BLANK ROAD MAP GUIDANCE. RESULTS: FAILURE OF EMBOLIZATION IN THE ONYX GROUP OCCURRED IN 6/49 (12.2%).  NEED OF UNPLANNED SURGICAL EVACUATION OCCURRED IN 5/49 (10.2%). THERE WERE NO COMPLICATIONS REPORTED IN EITHER GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369698 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention