BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOBO VASCULAR OCCLUSION SYSTEM

    MDR report key: 24285433 · Received February 7, 2026

    Report

    Report Number
    3016444913-2026-00002
    Event Type
    Malfunction
    Date Received
    February 7, 2026
    Date of Event
    January 6, 2026
    Report Date
    February 6, 2026
    Manufacturer
    OKAMI MEDICAL INC.
    Product Code
    KRD
    PMA / PMN Number
    K203025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PATIENT ADVERSE EFFECTS WAS REPORTED. THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL LOBO-5 DEVICE, WITHOUT FURTHER INCIDENT. THE PHYSICIAN REPORTED THAT THE VESSEL MAY HAVE BEEN MEASURED INCORRECTLY, AND THAT USE OF A LOBO-7 DEVICE MAY HAVE BEEN MORE APPROPRIATE FOR THE PROCEDURE. IN ADDITION, THE LANDING ZONE WAS REPORTED TO BE HIGHLY TORTUOUS, WHICH MAY HAVE EXACERBATED THE SIZING ISSUE AND CONTRIBUTED TO THE REPORTED MIGRATION. THE LOBO-5 DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, THE DEVICE WAS NOT RETURNED AND AN EVALUATION CANNOT BE CONDUCTED. A DHR REVIEW OF THE LOT NUMBER ASSOCIATED WITH THE DEVICE REVEALED THAT THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS AND THAT THE DEVICE WAS RELEASED WITHIN SPECIFICATIONS AND ACCEPTABLE PARAMETERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A SPLENIC BLEED, A PHYSICIAN IMPLANTED A LOBO VASCULAR OCCLUSION SYSTEM DEVICE (MODEL LOBO-5). THE DEVICE MIGRATED APPROXIMATELY 1 CM FROM THE INITIAL DEPLOYMENT LOCATION. THE PHYSICIAN REPORTED THAT THE VESSEL MAY HAVE BEEN MEASURED INCORRECTLY, AND THAT USE OF A LOBO-7 DEVICE MAY HAVE BEEN MORE APPROPRIATE FOR THE PROCEDURE. IN ADDITION, THE LANDING ZONE WAS REPORTED TO BE HIGHLY TORTUOUS, WHICH MAY HAVE EXACERBATED THE SIZING ISSUE AND CONTRIBUTED TO THE REPORTED MIGRATION. THE DEVICE SUBSEQUENTLY SETTLED IN PLACE AND DID NOT MIGRATE FURTHER; HOWEVER, IT WAS REPORTED THAT THE DEVICE DID NOT ACHIEVE COMPLETE OCCLUSION. A SECOND LOBO VASCULAR OCCLUSION SYSTEM DEVICE (MODEL LOBO-5) WAS IMPLANTED PROXIMAL TO THE FIRST DEVICE, AFTER WHICH THE VESSEL WAS SUCCESSFULLY OCCLUDED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347165 LOBO VASCULAR OCCLUSION SYSTEM VASCULAR EMBOLIZATION DEVICE KRD OKAMI MEDICAL INC. LOBO-5 25H0011

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other