BEUDAMED
    FDA Adverse Event Death Summary report: N

    LOBO VASCULAR OCCLUSION SYSTEM

    MDR report key: 23931098 · Received December 30, 2025

    Report

    Report Number
    3016444913-2025-00002
    Event Type
    Death
    Date Received
    December 30, 2025
    Date of Event
    November 27, 2025
    Report Date
    December 30, 2025
    Manufacturer
    OKAMI MEDICAL INC.
    Product Code
    KRD
    UDI-DI
    00850008222061
    PMA / PMN Number
    K220383
    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

    THE PATIENT DID NOT HAVE EVIDENCE OF COAGULOPATHY ON (B)(6) 2025 BASED ON AVAILABLE LABS (INR, CMP, CBC WERE ALL SATISFACTORY). ON (B)(6) 2025, AFTER EXPERIENCING MASSIVE GASTRIC VARIX BLEEDING, THE PATIENT RECEIVED AGGRESSIVE RESUSCITATION WITH MULTIPLE ROUNDS OF MASSIVE TRANSFUSION PROTOCOL. THE PHYSICIAN REPORTED THAT THE PATIENT LIKELY DEVELOPED A COAGULOPATHIC STATE FOLLOWING MASSIVE TRANSFUSION PROTOCOL AND THAT THIS CONDITION, PLUS THE HIGH PORTAL HYPERTENSION, LIKELY CONTRIBUTED TO THE REPORTED OUTCOME AND THE OBSERVED PATENCY OF THE PREVIOUSLY EMBOLIZED VESSELS. 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. THE LOBO VASCULAR OCCLUDER REMAINS IMPLANTED IN THE PATIENT; ONLY THE PUSHERWIRE COMPONENT OF THE LOBO VASCULAR OCCLUDER WAS RETURNED FOR EVALUATION. UPON VISUAL AND DIMENSIONAL INSPECTION OF THE RETURNED PUSHERWIRE COMPONENT, NO DEFECTS OR ABNORMALITIES WERE OBSERVED. A REVIEW OF ALL COMPLAINTS REVEALED NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED WITH REGARD TO THE REPORTED ISSUE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT UNDERWENT PORTAL VEIN THROMBECTOMY AND THROMBOLYSIS, ALONG WITH PLUG-ASSISTED ANTEROGRADE TRANSVENOUS OBLITERATION (PATO) VIA A PERCUTANEOUS TRANSHEPATIC APPROACH, TO REDUCE THE RISK ASSOCIATED WITH RECENTLY BLEEDING HIGH-RISK GASTRIC VARICES AND TO RESTORE PATENCY OF THE MAIN PORTAL VEIN THROMBUS. SUCCESSFUL VARIX EMBOLIZATION WAS ACHIEVED USING THE LOBO VASCULAR OCCLUSION SYSTEM DEVICES AND GELFOAM BY THE CONCLUSION OF THE PROCEDURE. THE PATIENT WAS DISCHARGED TO FLOOR ROOM IN STABLE CONDITION WITHOUT ANY CONCERNS. OVERNIGHT ON (B)(6) 2025, THE PATIENT BEGAN BLEEDING AND WAS BROUGHT EMERGENTLY FOR ACTIVE HEMORRHAGE FROM THE GASTRIC VARIX (AS NOTED BY EMERGENT BEDSIDE UPPER ENDOSCOPY). THE PATIENT BECAME ANEMIC/UNSTABLE AND THUS WAS AGGRESSIVELY RESUSCITATED IN A 'MASSIVE TRANSFUSION PROTOCOL' (MTP) FASHION. EMERGENT TIPS WAS CREATED FOR PORTAL ACCESS AND PORTAL HYPERTENSION DECOMPRESSION. PORTAL VENOGRAPHY DEMONSTRATED PATENT RECENTLY EMBOLIZED VARIX VESSELS - WITH ACTIVE EXTRAVASATION FROM THE GASTRIC VARIX ON THE OTHER SIDE OF THE LOBO VASCULAR OCCLUDERS. TO ADDRESS THE VARIX BLEED, ONE OF THE LOBO VASCULAR OCCLUDERS WAS REPORTEDLY BYPASSED USING A WIRE/MICROCATHETER TECHNIQUE, AND THE MAIN VARIX WAS SUBSEQUENTLY EMBOLIZED WITH COILS AND GELFOAM SUCCESSFULLY. NO FURTHER VARIX ACTIVE EXTRAVASATION VISUALIZED BY END OF THE PROCEDURE ON (B)(6) 2025; HOWEVER, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2708110 LOBO VASCULAR OCCLUSION SYSTEM VASCULAR EMBOLIZATION DEVICE KRD OKAMI MEDICAL INC. LOBO-9 25F0009 00850008222061

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Death