BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX

    MDR report key: 20408798 · Received October 9, 2024

    Report

    Report Number
    2029214-2024-01814
    Event Type
    Death
    Date Received
    October 9, 2024
    Date of Event
    May 9, 2023
    Report Date
    October 9, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: GALASTRI, F. L., VALLE, L. G., M., CUNHA, M. J. S., SCHMID, B. P., GARCIA, R. G>, LEWI, D. S., AFFONSO, B. B., NASSER, F.. A NOVEL BALLOON-ASSISTED TECHNIQUE TO SECURE VISCERAL CATHETERIZATION DURING A CHIMNEY ENDOVASCULAR REPAIR OF A RUPTURED ABDOMINAL AORTIC ANEURYSM IN A CENTENARIAN PATIENT. J VASC BRAS. 22:E20230018 2023. DOI: 10.1590/1677-5449.202300182. 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 SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    STUDY TITLE OR OBJECTIVE: A NOVEL BALLOON-ASSISTED TECHNIQUE TO SECURE VISCERAL CATHETERIZATION DURING A CHIMNEY ENDOVASCULAR REPAIR OF A RUPTURED ABDOMINAL AORTIC ANEURYSM IN A CENTENARIAN PATIENT. STUDY TIME FRAME: (B)(6) 2020 TO 2022. MEDTRONIC DEVICES USED: ONYX 18, MEDTRONIC-COVIDIEN, IRVINE, CA. DEATHS IN STUDY POPULATION: A PATIENT DEATH WAS REPORTED CAUSES OF DEATH: THE PATIENT DIED ON POSTOPERATIVE DAY 59 DUE TO RESPIRATORY COMPLICATIONS. ADVERSE EVENTS AND COMPLICATIONS: A (B)(6) YEAR-OLD MALE CAUCASIAN PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT OF A TERTIARY HOSPITAL IN (B)(6) 2022 WITH SUDDEN INTENSE ABDOMINAL PAIN AND HEMODYNAMIC COLLAPSE. THE FIRST REINTERVENTION WAS PERFORMED IN (B)(6) 2020 USING DIRECT PERCUTANEOUS ANEURYSM SAC PUNCTURE AND INJECTION OF AN ETHYLENE¿VINYL ALCOHOL COPOLYMER LIQUID EMBOLIC AGENT (ONYX 18, MEDTRONIC-COVIDIEN, IRVINE, CA). DESPITE ALL EFFORTS, THE PATIENT¿S ANEURYSM SAC CONTINUED TO EXPAND (MAXIMUM DIAMETER: 11 CM) AND SO A SECOND REINTERVENTION WAS PERFORMED IN (B)(6) 2021 USING A PERCUTANEOUS APPROACH AND SUPERSELECTIVE ANGIOGRAPHY TO ADMINISTER A PRECIPITATING HYDROPHOBIC INJECTABLE LIQUID ((B)(6), MICROVENTION, (B)(6)) INJECTION. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15562 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Male Death