BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 20483955 · Received October 18, 2024

    Report

    Report Number
    2029214-2024-01935
    Event Type
    Injury
    Date Received
    October 18, 2024
    Date of Event
    February 22, 2024
    Report Date
    October 18, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: KIM, M.-K., PARK, Y.-J., YANG, S.-S., KIM, D.-I., KIM, J.-G., HYUN, D.-H., PARK, K.-B., DO, Y.-S., & KIM, Y.-W.. COMPARISON BETWEEN ONYX AND COIL EMBOLIZATION FOR PERSISTENT TYPE 2 ENDOLEAKS AFTER ENDOVASCULAR ANEURYSM REPAIR. ANNALS OF SURGICAL TREATMENT AND RESEARCH 106(3), 178¿187 2024. DOI:10.4174/ASTR.2024.106.3.178. A.2. THIS VALUE IS THE MEAN AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE SEX 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 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

    LITERATURE WAS REVIEWED REGARDING THE "COMPARISON BETWEEN ONYX AND COIL EMBOLIZATION FOR TYPE 2 ENDOLEAKS AFTER ENDOVASCULAR ANEURYSM REPAIR". THE TIME FRAME OF THIS STUDY WAS BETWEEN AUGUST 2005 AND JULY 2022. INCLUDED IN THIS STUDY WERE 46 PATIENTS WHO UNDERWENT ENDOVASCULAR EMBOLIZATION FOR TREATMENT OF TYPE 2 ENDOLEAKS (T2EL) (15 ONYX AND 31 COILS). MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: ONYX AND CONCERTO COILS DEATH OCCURRED IN THE STUDY POPULATION. ONE ONYX PATIENT DIED OF CANCER. EIGHT COIL PATIENTS DIED (CAUSES INCLUDE 1 GRAFT INFECTION, 1 RUPTURE, 1 STENT MIGRATION AND BLEEDING, 1 REPERFUSION INJURY, 1 FROM CANCER, AND 3 UNKNOWN/FOLLOW UP LOSS; 3 WERE ANEURYSM RELATED DEATHS) AMONG PATIENT ADVERSE EVENTS INCLUDED: -ENDOLEAK RESOLVED IN 5/15 ONYX PATIENTS AND 12/31 COIL PATIENTS. -ANEURYSM SAC GROWTH OF MORE THAN 5MM OCCURRED IN 3 ONYX PATIENTS AND 16 COIL PATIENTS -REINTERVENTION WAS NEEDED IN 2 ONYX PATIENTS (OPEN CONVERSION) AND 12 COIL PATIENTS (4 COIL EMBOLIZATION, 6 OPEN CONVERSION, AND 2 COMBINATION) NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1972380 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ONYX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention