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

Model Number	LOBO-9
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A representative reported that during a pavm procedure, a large pulmonary artery branch did not achieve occlusion approximately 20 minutes after a lobo-9 vascular occlusion system device was detached in the intended vessel.The vessel was reported to measure approximately 8 mm in diameter.The physician waited an additional five (5) minutes and subsequently deployed a second lobo-9 device proximal to the initial device.After an additional 15 minutes, flow was observed to decrease; however, complete occlusion was not achieved.
Additional Manufacturer Narrative
No patient injury was reported in association with this event.The physician plans to perform a follow-up ct scan in approximately 30 days to assess vessel occlusion.The lobo-9 devices remain implanted.A review of the device history record (dhr) identified no manufacturing deviations that could have contributed to the reported event.

• 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: 24779630
• Report Number: 3016444913-2026-00009
• Device Sequence Number: 6133319
• Product Code: KRD
• UDI-Device Identifier: 00850008222061
• UDI-Public: 01008500082220611025L000317270117
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K220383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LOBO-9
• Device Lot Number: 25L0003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2025
• 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: Other
• Patient Age: 78 YR
• Patient Sex: Unknown