BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 17351741 · Received July 19, 2023

    Report

    Report Number
    2029214-2023-01142
    Event Type
    Injury
    Date Received
    July 19, 2023
    Date of Event
    May 17, 2022
    Report Date
    July 19, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: SAMARAGE, H. M., KIM, W. J., ZARRIN, D., GOEL, K., CHIN-HSIU WANG, A., JOHNSON, J., KANEKO, N., NOUR, M., SZEDER, V., TATESHIMA, S., JAHAN, R., DUCKWILER, G., <(>&<)> COLBY, G. P.. THE ¿BRIGHT FALX¿ SIGN¿MIDLINE EMBOLIC PENETRATION IS ASSOCIATED WITH FASTER RESOLUTION OF CHRONIC SUBDURAL HEMATOMA AFTER MIDDLE MENINGEAL ARTERY EMBOLIZATION: A CASE SERIES. NEUROSURGERY 91(3):389-398. 2022. DOI:10.1227/NEU.0000000000002038 A.2. THIS VALUE IS THE AVERAGE 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

    SAMARAGE HM, KIM WJ, ZARRIN D, ET AL. THE ¿BRIGHT FALX¿ SIGN¿MIDLINE EMBOLIC PENETRATION IS ASSOCIATED WITH FASTER RESOLUTION OF CHRONIC SUBDURAL HEMATOMA AFTER MIDDLE MENINGEAL ARTERY EMBOLIZATION: A CASE SERIES. NEUROSURGERY. 2022;91(3):389-398. DOI:10.1227/NEU. 0000000000002038 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH ONYX. THE PURPOSE OF THIS ARTICLE WAS TO REPORT A RETROSPECTIVE CASE SERIES OF MIDDLE MENINGEAL ARTERY (MMA)EMBOLIZATION FOR CHRONIC SUBDURAL HEMATOMAS (CSDHS) REGARDING RATE OF HEMATOMA IMPROVEMENT AND THE SIGNIFICANCE OF DISTAL EMBOLIC PENETRATION INTO THE FALX. A RETROSPECTIVE CHART ANALYSIS WAS CONDUCTED ON ALL CONSECUTIVE PATIENTS WHO UNDERWENT MMA EMBOLIZATION AT A SINGLE ACADEMIC MEDICAL CENTER BETWEEN JANUARY 2017 AND JUNE 2021. IN TOTAL, 40 CONSECUTIVE PATIENTS UNDERWENT ATTEMPTS AT MMA EMBOLIZATION FOR A TOTAL OF 56 HEMISPHERES WITH CSDHS DURING THE STUDY PERIOD. THE MEAN AGE OF PATIENTS WAS 76.9 YEARS WITH A MALE PREPONDERANCE. NINETY-FIVE PERCENT OF THE PATIENTS IN THE COHORT (35 OF 37) UNDERWENT GENERAL ANESTHESIA, AND 2 PATIENTS UNDERWENT CONSCIOUS SEDATION FOR THE EMBOLIZATION. PROCEDURES WERE PERFORMED BY 6 TRAINED NEUROINTERVENTIONALISTS. THE INDIVIDUAL PRACTITIONER DETERMINED THE EMBOLIC AGENT(S) AND TECHNIQUE. THE RIGHT COMMON FEMORAL ARTERY WAS THE DEFAULT ACCESS SITE. MOST PATIENTS (84%, 31 OF 37) UNDERWENT TRANSFEMORAL ACCESS, WITH 16% (6 OF 37) UNDERGOING TRANSRADIAL ACCESS. EIGHTY-SEVEN PERCENT OF CSDHS (46 OF 53) UNDERWENT EMBOLIZATION OF BOTH FRONTAL AND PARIETAL BRANCHES OF THE MMA. EMBOLIC AGENTS USED WERE AS FOLLOWS: 38 OF 53 (72%) USED NBCA, 9 OF 53 (17%) USED PVA PARTICLES, 3 OF 53 (6%) USED ONYX, AND 20 OF 53 (38%) USED COILS FOR PROXIMAL OCCLUSION; 17 OF 53 (32%) CASES USED A COMBINATION OF THE ABOVE EMBOLIC MATERIALS. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE ONYX. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: -ONE PATIENT¿S PROCEDURE WAS ABORTED BECAUSE OF DANGEROUS ANASTOMOSES FROM THE MMA TO THE OPHTHALMIC ARTERY -FIVE OF 40 PATIENTS WHO UNDERWENT MMA EMBOLIZATION REQUIRED RESCUE SURGICAL INTERVENTIONS AFTER THEIR MMA EMBOLIZATION, INCLUDING BURR HOLE DRAINAGE OR CRANIOTOMY, BECAUSE OF SYMPTOMATIC MASS EFFECT FROM THEIR SUBDURAL HEMATOMAS; 2 PATIENTS HAD AN INTERVAL INCREASE IN SUBDURAL COLLECTIONS AND A DEVELOPMENT OF NEW SYMPTOMS IN THE OTHER 3. -THREE DIRECT PROCEDURE-RELATED COMPLICATIONS INCLUDED AN AORTIC DISSECTION, A COMMON FEMORAL ARTERY PSEUDOANEURYSM, AND AN MMA  VESSEL INJURY, THE LATTER OF WHICH LED TO AN IATROGENIC MMA TO VEIN FISTULA. THE COMMON FEMORAL ARTERY PSEUDOANEURYSM REQUIRED ELECTIVE OPEN SURGICAL REPAIR LATER. -EIGHTY-FOUR PERCENT OF PATIENTS (31 OF 37) SHOWED REDUCTION IN VOLUMES OF CSDHS, AND 49% OF PATIENTS (18 OF 37) WENT ON TO HAVE COMPLETE RESOLUTION OF THEIR CSDHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43030 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention