BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOBO VASCULAR OCCLUSION SYSTEM

    MDR report key: 24779630 · Received April 3, 2026

    Report

    Report Number
    3016444913-2026-00009
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 2, 2026
    Report Date
    April 3, 2026
    Manufacturer
    OKAMI MEDICAL INC.
    Product Code
    KRD
    UDI-DI
    00850008222061
    PMA / PMN Number
    K220383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PATIENT INJURY WAS REPORTED IN ASSOCIATION WITH THIS EVENT. THE PHYSICIAN PLANS TO PERFORM A FOLLOW-UP CT SCAN IN APPROXIMATELY 30 DAYS TO ASSESS VESSEL OCCLUSION. THE LOBO-9 DEVICES REMAIN IMPLANTED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IDENTIFIED NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    A REPRESENTATIVE REPORTED THAT DURING A PAVM PROCEDURE, A LARGE PULMONARY ARTERY BRANCH DID NOT ACHIEVE OCCLUSION APPROXIMATELY 20 MINUTES AFTER A LOBO-9 VASCULAR OCCLUSION SYSTEM DEVICE WAS DETACHED IN THE INTENDED VESSEL. THE VESSEL WAS REPORTED TO MEASURE APPROXIMATELY 8 MM IN DIAMETER. THE PHYSICIAN WAITED AN ADDITIONAL FIVE (5) MINUTES AND SUBSEQUENTLY DEPLOYED A SECOND LOBO-9 DEVICE PROXIMAL TO THE INITIAL DEVICE. AFTER AN ADDITIONAL 15 MINUTES, FLOW WAS OBSERVED TO DECREASE; HOWEVER, COMPLETE OCCLUSION WAS NOT ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114213 LOBO VASCULAR OCCLUSION SYSTEM VASCULAR EMBOLIZATION DEVICE KRD OKAMI MEDICAL INC. LOBO-9 25L0003 00850008222061

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Unknown Other