BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX

    MDR report key: 17375641 · Received July 22, 2023

    Report

    Report Number
    2029214-2023-01160
    Event Type
    Death
    Date Received
    July 22, 2023
    Date of Event
    August 6, 2020
    Report Date
    July 21, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: UNK-NV-ONYX; PRODUCT TYPE: G2: CITATION: AUTHORS: LIU, P., CHEN, X., YOU, W., LI, Y., LV, M., LV, X.. HEMORRHAGIC RISK FACTORS OF ENDOVASCULAR ONYX EMB OLIZATION OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULAS. INTERVENTIONAL NEURORADIOLOGY 26(5):643-650 2020. DOI:10.1177/1591019920953261. 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.

    Description of Event or Problem · 0

    LIU P, CHEN X, YOU W, LI Y, LV M, LV X. HEMORRHAGIC RISK FACTORS OF ENDOVASCULAR ONYX EMBOLIZATION OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULAS. INTERVENTIONAL NEURORADIOLOGY. 2020;26(5):643-650. DOI:10.1177/1591019920953261. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH ONYX LIQUID EMBOLIC. THE PURPOSE OF THIS ARTICLE WAS TO ANALYZE THE POSSIBLE RISK FACTORS FOR THE HEMORRHAGIC COMPLICATION CAUSED BY ENDOVASCULAR EMBOLIZATION OF DURAL ARTERIOVENOUS FISTULAS (DAVFS). A TOTAL OF 267 PATIENTS WITH INTRACRANIAL DAVFS WHO RECEIVED ENDOVASCULAR ONYX EMBOLIZATION WERE INCLUDED IN THE STUDY. THE MEAN AGE WAS 47.4 YEARS, AND INCLUDED 166 MALES AND 101 FEMALES. AMONG THE 267 PATIENTS, ONE EMBOLIZATION PROCEDURE WAS PERFORMED IN 232 PATIENTS, TWO PROCEDURES IN 29 PATIENTS AND MORE THAN TWO PROCEDURES IN 6 PATIENTS. ADDITIONAL RADIOSURGERY WAS PERFORMED IN 8 PATIENTS. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE ONYX. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED:  - HEMORRHAGIC COMPLICATION OCCURRED IN 12 (4.5%) PATIENTS: 9 (75%) NON-SINUS AND 3 (25%) SINUS DAVFS. NINE (75%) PATIENTS WERE MALE AND 3 (25%) WERE FEMALE. THE MEAN AGE WAS 45.3 YEARS. THE PROCEDURE-RELATED HEMORRHAGIC COMPLICATION WAS ACCORDING TO THE CT EXAMINATION WITHIN 30 DAYS AFTER PROCEDURE. OF THE PATIENTS WITH HEMORRHAGIC COMPLICATION, TWO PATIENTS DIED OF SEVERE INTRACRANIAL HEMORRHAGE, TWO PATIENTS SUFFERED SEVERE DISABILITY (MRS, 4), AND THE OTHER EIGHT PATIENTS ALL RECOVERED UNEVENTFULLY WITH NO NEUROLOGICAL DEFICITS.  - ONE OF THE PATIENTS WITH HEMORRHAGIC COMPLICATIONS SUFFERED SEVERE HEADACHE AND A SUDDEN ONSET OF UNCONSCIOUSNESS SIX HOURS AFTER THE PROCEDURE. AN ACUTE CT SCAN SHOWED A HYPERDENSITY WITHIN THE VENOUS ANEURYSM CONSISTENT WITH ACUTE THROMBOSIS AND HEMATOMA. THE FOLLOWING DAY, THE PATIENT¿S NEUROLOGICAL CONDITION CONTINUED TO DECLINE AND CT SCAN SHOWING THE HYPERDENSE REGION ENLARGED.  - ANOTHER OF THE PATIENTS WITH HEMORRHAGIC COMPLICATIONS SUFFERED A SUDDEN ONSET OF UNCONSCIOUSNESS TWO HOURS AFTER THE PROCEDURE. AN ACUTE CT SCAN SHOWED A HYPERDENSITY WITHIN THE VENOUS ANEURYSM CONSISTENT WITH HEMATOMA. EMERGENCY SURGERY WAS PERFORMED AND CONTROL CT SCAN SHOWING THE HEMATOMA AS WELL AS THE VENOUS POUCH WAS COMPLETELY REMOVED.  - THREE TOTAL PATIENT DEATHS (1.1%) WERE FOUND IN THE SERIES.  - FOUR TOTAL PATIENTS (1.5%) HAD MILD OR MODERATE DISABILITY (MRS, 2 OR 3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922585 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Death