BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX

    MDR report key: 17410403 · Received July 27, 2023

    Report

    Report Number
    2029214-2023-01208
    Event Type
    Death
    Date Received
    July 27, 2023
    Date of Event
    January 1, 2018
    Report Date
    July 27, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. CONTINUATION OF D10: PRODUCT ID UNK-NV-ONYX; PRODUCT TYPE: ; IMPLANT DATE ; EXPLANT DATE G2: CITATION: AUTHORS: RABUFFI P, BRUNI A, ANTONUCCIO E, SARACENI A, VAGNARELLI S. TRANSARTERIAL EMBOLIZATION OF ACUTE NON-NEUROLOGIC BLEEDING USING ETHYLENE VYNIL ALCOHOL COPOLYMER: A SINGLE-CENTRE RETROSPECTIVE STUDY. CVIR ENDOVASCULAR 6:2 2023. HTTPS://DOI.ORG/ 10.1186/S42155-023-0034 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

    (B)(6) 2021, 211 PATIENTS (MALE 123, MEAN AGE 69.7 Y + 17.9) WHO UNDERWENT TRANSARTERIAL EMBOLIZATION WITH ONYX¿ FOR ACUTE NON-NEUROLOGIC ARTERIAL BLEEDING WERE RETROSPECTIVELY REVIEWED. MOST FREQUENT ETIOLOGY OF BLEEDING WAS POST-OPERATIVE (89/211, 42.2%), TRAUMA (62/211, 29.4%) AND TUMOR (18/211, 8.5%). TECHNICAL SUCCESS WAS DEFINED AS THE ANGIOGRAPHIC EVIDENCE OF TARGET VESSEL COMPLETE OCCLUSION. CLINICAL SUCCESS WAS DEFINED AS RESOLUTION OF BLEEDING. ANY REBLEEDING WITHIN THE PRIMITIVE SITE, REQUIRING A NEW INTERVENTION DURING THE FIRST 30-DAYS FOLLOWING EMBOLIZATION, WAS CONSIDERED A CLINICAL FAILURE. OCCURRENCE OF PROCEDURE-RELATED COMPLICATION AND MORTALITY WITHIN 30DAYS OF THE EMBOLIZATION WERE EXAMINED.   A TOTAL OF 229 EMBOLIZATION PROCEDURES WAS PERFORMED IN 211 PTS.; TECHNICAL SUCCESS RATE WAS 99.5% (210/211 PTS). CLINICAL SUCCESS RATE WAS 94.3% (199/211 PTS). IN 11 PATIENTS (5.2%) A REINTERVENTION WAS NEEDED BECAUSE OF A REBLEEDING OCCURRING WITHIN THE PRIMITIVE SITE, WHEREAS IN FIVE PATIENTS (2.4%) REBLEEDING OCCURRED WITHIN A SITE DIFFERENT FROM THE PRIMITIVE. FACTORS MORE OFTEN ASSOCIATED WITH CLINICAL FAILURE WERE COAGULOPATHY/ONGOING ANTICOAGULANT THERAPY (5/11, 45.4%), AND POST-OPERATIVE ETIOLOGY (3/11, 27.3%). EVOH WAS USED AS THE SOLE EMBOLIC AGENT IN 214/229 PROCEDURES (93.4%), IN ASSOCIATION WITH COILS IN 11 CASES (4.8%), AND WITH MICROPARTICLES IN 4 CASES (1.7%). IN THE PRESENT SERIES, MAJOR COMPLICATIONS OCCURRED IN 6 CASES (2.8%): RESPECTIVELY, FOUR CASES (1.9%) OF COLONIC ISCHEMIA AND TWO GROIN HEMATOMAS (0.9%) WITH ACTIVE EXTRAVASATION WERE OBSERVED. 26 (12.3%) PATIENTS DIED DURING THE FOLLOW-UP. ONE PATIENT, WHO UNDERWENT COLECTOMY BECAUSE OF COLONIC ISCHEMIA FOLLOWING TE, DIED FOR MULTIORGAN FAILURE AFTER 7 DAYS. THE OTHER 25 PATIENTS DIED FOR THE CONSEQUENCES OF TRAUMA (7/25), OR BECAUSE OF THE SEVERITY OF THEIR UNDERLYING DISEASE (18/25).   EMBOLIZATION OF ACUTE ARTERIAL BLEEDING WITH EVOH AS A FIRST-LINE EMBOLIC AGENT IS FEASIBLE, SAFE AND EFFECTIVE. ADVERSE EVENTS INCLUDED: 1. COLONIC ISCHEMIA 2. GROIN HEMATOMAS 3. MULTIORGAN FAILURE 4. PATIENTS DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2320535 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death