BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOBO VASCULAR OCCLUSION SYSTEM

    MDR report key: 24613621 · Received March 16, 2026

    Report

    Report Number
    3016444913-2026-00006
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    August 17, 2020
    Report Date
    March 16, 2026
    Manufacturer
    OKAMI MEDICAL INC.
    Product Code
    KRD
    UDI-DI
    00850008222016
    PMA / PMN Number
    K192083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO INJURY WAS ASSOCIATED WITH THE REPORTED INCIDENT, AND NO MEDICAL INTERVENTION WAS REQUIRED; THE DEVICE WAS LEFT IN SITU WITHOUT CLINICAL SEQUELAE. THE DEVICE STILL OCCLUDED THE POTENTIAL FEEDER VESSEL AND THERE WERE NO COMPLICATIONS. THE DEVICE WAS PLACED IN A LARGER VESSEL THAN INDICATED FOR USE. THE PHYSICIAN DETERMINED THE DEVICE WAS PLACED APPROPRIATELY AND WAS SAFE AND EFFECTIVE. NO ADDITIONAL FOLLOW-UP WAS NEEDED SPECIFICALLY FOR THE MIGRATION AS DETERMINED BY THE PHYSICIAN. THE DEVICE WAS NOT RETURNED FOR EVALUATION; A MANUFACTURING RECORD REVIEW REVEALED NO DEVIATIONS RELEVANT TO THE COMPLAINT INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERGOING AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE HAD A BRANCH OF THE INFERIOR MESENTERIC ARTERY (IMA) IDENTIFIED AS A POTENTIAL FEEDER VESSEL. THE PHYSICIAN ELECTED TO OCCLUDE THE VESSEL TO REDUCE THE RISK OF A FUTURE ENDOLEAK AND DEPLOYED A LOBO-3 OCCLUDER. THE PHYSICIAN ESTIMATED THE VESSEL DIAMETER TO BE BETWEEN 3-4 MM AND PROCEEDED WITH USE OF THE DEVICE OUTSIDE ITS INTENDED VESSEL SIZE RANGE, ACKNOWLEDGING AN INCREASED RISK OF MIGRATION. THE STENT GRAFT WAS SUBSEQUENTLY PLACED AND EXPANDED. APPROXIMATELY 5 MINUTES AFTER LOBO DEPLOYMENT, THE PHYSICIAN OBSERVED THAT THE DEVICE HAD MIGRATED APPROXIMATELY 5 MM. A POST-PROCEDURE MEASUREMENT DETERMINED THE VESSEL DIAMETER TO BE 4.08 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674890 LOBO VASCULAR OCCLUSION SYSTEM VASCULAR EMBOLIZATION DEVICE KRD OKAMI MEDICAL INC. LOBO-3 20C0004 00850008222016

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other