MAUDE Adverse Event Report: OKAMI MEDICAL INC. LOBO VASCULAR OCCLUSION SYSTEM; VASCULAR EMBOLIZATION DEVICE

Model Number	LOBO-9
Medical Device Problem Codes	Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/27/2025
Type of Reportable Event	Death
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: LOBO VASCULAR OCCLUSION SYSTEM
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): OKAMI MEDICAL INC.; 8 argonaut; suite 100; aliso viejo CA 92656
• Manufacturer (Section G): OKAMI MEDICAL INC.; 8 argonaut; suite 100; aliso viejo CA 92656
• Manufacturer Contact: cora sim ; 8 argonaut; suite 100; aliso viejo, CA 92656 ; 9494469710
• MDR Report Key: 23931098
• Report Number: 3016444913-2025-00002
• Device Sequence Number: 9611150
• Product Code: KRD
• UDI-Device Identifier: 00850008222061
• UDI-Public: 01008500082220611025F000917260826
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K220383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2026
• Device Model Number: LOBO-9
• Device Catalogue Number: LOBO-9
• Device Lot Number: 25F0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 63 YR
• Patient Sex: Male