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

Model Number LOBO-7

Device Problem Migration (4003)

Patient Problems Necrosis (1971); Pain (1994); Pulmonary Edema (2020); Inadequate Pain Relief (2388); Hypervolemia (2664); Device Embedded In Tissue or Plaque (3165)

Event Date 06/22/2023

Event Type  Injury  

Manufacturer Narrative

The lobo-7 device remains implanted in the patient, remains stable, and is not available for evaluation.The device identifiers were provided and the lot history records were reviewed; there were no deviations or nonconformances relevant to the reportable event.Intraoperative images were sent to the manufacturer for evaluation and the investigation is underway.The findings will be filed in a supplemental report.Implant migration and occlusion of unintended vessel are listed in the device labeling as potential complications / adverse events.Reference #: (b)(4).

Event Description

Patient was treated for a splenic artery aneurysm measuring 2.5 - 3 cm.A lobo-7 device was deployed in the splenic artery distal to the aneurysm and migrated into an upper pole branch of the splenic artery.The device could not be retrieved with a snare and the physician elected to leave it in place.The aneurysm was successfully treated with lobo-9 and embolic coils.The spleen was partially infarcted, but no long-term effects to splenic function are anticipated by the physician.Patient was discharged following the procedure with pain medication.The patient returned to the hospital and was admitted for pain management.During hospitalization, the patient was treated for pain and fluid overload (including pulmonary edema), and was subsequently discharged.

Manufacturer Narrative

Angiographic images were sent to the manufacturer and evaluated.Based on the image and dimensional analysis, it was determined that the lobo-7 device was placed in a vessel larger than indicated for use.The investigation concluded that the implant migration was attributed to inadvertent use error and there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.Reference #: (b)(4).

• Brand Name: LOBO VASCULAR OCCLUDER
• Type of Device: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): OKAMI MEDICAL INC.; 8 argonaut; suite 100; aliso viejo CA 92656
• Manufacturer (Section G): INCEPTUS MEDICAL LLC; 8 argonaut; suite 100; aliso viejo CA 92656
• Manufacturer Contact: jill delsman ; 8 argonaut; suite 100; aliso viejo, CA 92656 ; 9494469710
• MDR Report Key: 17376052
• MDR Text Key: 319663484
• Report Number: 3016444913-2023-00001
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00850008222030
• UDI-Public: 01008500082220301023D000
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2023
• Device Model Number: LOBO-7
• Device Catalogue Number: LOBO-7
• Device Lot Number: 23D0002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CERENOVUS ENVOY 6 FR GUIDING CATHETER.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White