BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOBO VASCULAR OCCLUSION SYSTEM

    MDR report key: 23251480 · Received October 8, 2025

    Report

    Report Number
    3016444913-2025-00001
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    September 9, 2025
    Report Date
    September 9, 2025
    Manufacturer
    OKAMI MEDICAL INC.
    Product Code
    KRD
    PMA / PMN Number
    K220383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOBO-9 DEVICE WAS RETRIEVED FROM THE PATIENT, AND THE TARGET VESSEL WAS OCCLUDED USING A DIFFERENT DEVICE. NO ADVERSE EFFECTS WERE REPORTED WITH REGARD TO THE PATIENT; THE PATIENT HAS FULLY RECOVERED AND IS DOING WELL. A DHR REVIEW REVEALED NO MANUFACTURING DEVIATIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE, AND THE DEVICE WAS RELEASED WITHIN SPECIFICATIONS AND ACCEPTABLE PARAMETERS.

    Description of Event or Problem · 0

    PATIENT WITH CONGENITAL HEART DEFECT WITH HISTORY OF ANOMALOUS VEIN SHUNT FROM HEPATIC VEIN TO CORONARY SINUS ABNORMALITY WAS UNDERGOING PROCEDURE TO EMBOLIZE THE ANOMALOUS VESSEL. A LOBO VASCULAR OCCLUSION SYSTEM DEVICE (MODEL: LOBO-9) WAS PLACED IN THE TARGET VESSEL. THE LOBO-9 DEVICE WAS SUCCESSFULLY DEPLOYED AND DETACHED IN THE VESSEL; HOWEVER, UPON REVIEWING ANGIOGRAPHIC IMAGES, IT WAS ALLEGED THAT THE LOBO-9 DEVICE APPEARED TO HAVE BEEN DISPLACED TO THE AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565971 LOBO VASCULAR OCCLUSION SYSTEM VASCULAR EMBOLIZATION DEVICE KRD OKAMI MEDICAL INC. LOBO-9 25D0002

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Male Required Intervention BALKIN GUIDING SHEATH.