BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOBO VASCULAR OCCLUSION SYSTEM

    MDR report key: 24687166 · Received March 25, 2026

    Report

    Report Number
    3016444913-2026-00008
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    February 19, 2026
    Report Date
    March 20, 2026
    Manufacturer
    OKAMI MEDICAL INC.
    Product Code
    KRD
    UDI-DI
    00850008222061
    PMA / PMN Number
    K220383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO INJURY WAS ASSOCIATED WITH THE REPORTED INCIDENT AND THE PHYSICIAN REPORTED THAT THE OBSERVED MIGRATION WAS NOT CLINICALLY SIGNIFICANT; THE HIGH BLOOD FLOW OF THE SPLENIC ARTERY AND INCORRECT VESSEL SIZING MAY HAVE CONTRIBUTED TO THE MIGRATION. IT WAS ALSO REPORTED THAT THE PHYSICIAN USED TWO (2) ADDITIONAL COILS AFTER DEPLOYING THE LOBO-9 DEVICE TO ASSIST IN SLOWING DOWN THE BLOOD FLOW; IT WAS NOTED THAT THE PATIENT WAS ON BLOOD THINNING MEDICATION. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND WAS NOT RETURNED FOR EVALUATION; A DEVICE HISTORY RECORD REVIEW REVEALED THAT THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE AND THAT THE DEVICE WAS RELEASED WITHIN SPECIFICATIONS AND ACCEPTABLE PARAMETERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH AN ENLARGED SPLEEN AND NO EVIDENCE OF ACTIVE SPLENIC BLEEDING WAS SCHEDULED TO UNDERGO A SPLENECTOMY. THE PHYSICIAN ELECTED TO PERFORM A SPLENIC ARTERY EMBOLIZATION PRIOR TO SURGERY TO REDUCE BLEEDING RISK. THE TARGET VESSEL WAS REPORTED TO MEASURE APPROXIMATELY 6.8 MM IN DIAMETER. A LOBO-9 VASCULAR OCCLUSION SYSTEM DEVICE WAS SELECTED AND DEPLOYED FOR EMBOLIZATION. FOLLOWING DEVICE DEPLOYMENT AND DETACHMENT, IT WAS REPORTED THAT THE LOBO-9 DEVICE MIGRATED FORWARD BY APPROXIMATELY 1 CM FROM THE INTENDED PLACEMENT LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751358 LOBO VASCULAR OCCLUSION SYSTEM VASCULAR EMBOLIZATION DEVICE KRD OKAMI MEDICAL INC. LOBO-9 25H0012 00850008222061

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Other