MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER24; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	22-101
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The inari devices were discarded by the user facility and are not available for evaluation.The device identifiers were not provided; the lot history records of all potential lots shipped to the facility were reviewed.There were no discrepancies or unusual findings.There was no report of any device malfunction.Based on the information reviewed, there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.The case was reviewed by inari's chief medical officer, who concluded that the patient's injury was the result of inadvertent vessel perforation.Cardiac perforation and cardiac tamponade are identified in the labeling as possible adverse events/complications.Manufacturer's reference #: (b)(4).
Event or Problem Description
A 66-year-old male underwent a thrombectomy with the inari flowtriever system to address their pulmonary embolism.The majority of clot was successfully removed when the physician used the triever20 curve (t20c) through the triever24 (t24) to do a final walk back.The t24 was positioned in the left pulmonary artery (lpa) with the tip just before the curve of the lpa.The t20c cavitated on the final pull and was pulled back into the t24.As the t20c reached the inferior vena cava, the t24 was now over the "hump" of the lpa.The t24 was pulled back into the main pulmonary artery and imaging was performed.No perforation or extravasation was observed but the patient's heart rate jumped up to 122.This was followed by a fluctuation in blood pressure.A computed tomography angiography was performed which revealed a hemopericardium.A drain was placed where 850 cc of blood was removed but blood was still collecting in the heart.A tamponade was performed, and the patient was transferred to a sister facility.The patient was last reported to be stable and doing okay.

• Brand Name: TRIEVER24
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): INARI MEDICAL, INC.; 6001 oak canyon; suite 100; irvine CA 92618
• Manufacturer (Section G): INARI MEDICAL, INC.; 6001 oak canyon; suite 100; irvine CA 92618
• Manufacturer Contact: mazi kiani ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 9494132147
• MDR Report Key: 22294368
• Report Number: 3020347218-2025-00040
• Device Sequence Number: 18259595
• Product Code: QEW
• UDI-Device Identifier: 00850291007185
• UDI-Public: 00850291007185
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/19/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 22-101
• 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: 05/22/2025
• Initial Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FLOWSAVER; INTRI24 SHEATH; TRIEVER20 CURVE
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male