MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER20; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	21-101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	05/23/2025
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 deterioration was the result of inadvertent clot embolism.Distal embolization of blood clots is identified in the device labeling as possible adverse events/complications.Manufacturer reference #: (b)(4).
Event or Problem Description
A 58-year-old female presented with right leg deep vein thrombosis (dvt) after undergoing knee surgery 2 weeks prior.Thrombus was visualized throughout the femoral vein and either in or behind a venous stent.A computed tomography scan performed 2 days before the dvt procedure revealed that the patient also had minor pulmonary embolism with no right heart strain.The decision was made to use a triever20 (t20) to perform aspirations to address the dvt.Multiple aspirations were performed which yielded clot.Once the t20 made it to the common femoral vein, additional aspiration was performed and once no more clot could be removed, the catheter was brought back to the popliteal to do a venogram.This revealed no more clot all the way to the inferior vena cava.At this moment, the patient became tachycardic and began to deteriorate.The patient became unresponsive and the t20 was removed.The patient was placed supine on a stretcher to perform the advanced cardiac life support protocol.A code was called and after 15-30 minutes of coding, the patient established blood pressure and rhythm.A bolus of tpa was administered and the patient was transferred to the intensive care unit.Unfortunately, the patient expired later that evening.

• Brand Name: TRIEVER20
• 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 92618 ; 9494132147
• MDR Report Key: 22299779
• Report Number: 3020347218-2025-00041
• Device Sequence Number: 15887808
• Product Code: QEW
• UDI-Device Identifier: 00850291007093
• UDI-Public: 00850291007093
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 06/20/2025

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: 21-101
• 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: 05/23/2025
• Initial Report FDA Received Date: 06/20/2025
• 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: CLOTTRIEVER SHEATH, 16 FR; FLOWSAVER
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female