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

Model Number	LOBO-3
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• 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: 24613621
• Report Number: 3016444913-2026-00006
• Device Sequence Number: 10137746
• Product Code: KRD
• UDI-Device Identifier: 00850008222016
• UDI-Public: 01008500082220161020C000417201006
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 03/16/2026

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 Expiration Date: 10/06/2020
• Device Model Number: LOBO-3
• Device Lot Number: 20C0004
• 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: 08/18/2020
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2020
• 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: 72 YR
• Patient Sex: Female