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

Model Number	LOBO-9
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No injury was associated with the reported incident and the physician reported that the observed migration was not clinically significant; the high blood flow of the splenic artery and incorrect vessel sizing may have contributed to the migration.It was also reported that the physician used two (2) additional coils after deploying the lobo-9 device to assist in slowing down the blood flow; it was noted that the patient was on blood thinning medication.The device remains implanted in the patient and was not returned for evaluation; a device history record review revealed that there were no deviations in the manufacturing process that could have contributed to the reported issue and that the device was released within specifications and acceptable parameters.
Event or Problem Description
It was reported that a patient with an enlarged spleen and no evidence of active splenic bleeding was scheduled to undergo a splenectomy.The physician elected to perform a splenic artery embolization prior to surgery to reduce bleeding risk.The target vessel was reported to measure approximately 6.8 mm in diameter.A lobo-9 vascular occlusion system device was selected and deployed for embolization.Following device deployment and detachment, it was reported that the lobo-9 device migrated forward by approximately 1 cm from the intended placement location.

• 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: 24687166
• Report Number: 3016444913-2026-00008
• Device Sequence Number: 9977232
• Product Code: KRD
• UDI-Device Identifier: 00850008222061
• UDI-Public: 01008500082220611025H001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/20/2026

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: 25H0012
• 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: 02/19/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2025
• 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: 34 YR
• Patient Sex: Female