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	08/04/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The inari devices were discarded by the user facility and are not available for evaluation.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 stryker medical affairs, who concluded that the patient's injury was possibly the result of inadvertent catheter perforation due to user error (advancing without a dilator).Cardiac perforation and cardiac tamponade are identified in the labeling as possible adverse events/complications.The device labeling includes the following warning: "do not advance the triever catheter without first reinserting the dilator.Failure to do so may result in vessel damage or perforation." manufacturer reference#: (b)(4).
Event or Problem Description
A 61-year-old female presented to the emergency department with shortness of breath.Imaging was performed and the patient was diagnosed with bilateral pulmonary embolism (pe) with heavy clot burden on both sides.Clot was also observed in the iliac and inferior vena cava.Access and wire positioning was achieved without issue.The access sheath was swapped out for the intri24 sheath.After removing the dilator, the triever24 (t24) was advanced into place.Aspirations were performed but yielded little to no clot.Cavitation also occurred so the physician pulled back the t24 until it filled.This occurred when the tip of the t24 was in the main pulmonary artery.When this occurred, the patient began to cough and experienced a small amount of hemoptysis.The physician advanced the t24 forward without a dilator to take an angiogram.No signs of perforation were seen so the procedure continued.Aspirations were performed but cavitation occurred again.When pulling the t24 back, the syringe was filled with a "jello-like" clot.After another aspiration the patient began to experience severe hemoptysis.Significant clot burden was observed in the syringe.Suction was performed and the t24 was pulled back which resulted in the loss of wire positioning.Fortunately, the patient's coughing and hemoptysis resolved itself in around 10 minutes.The patient began to rapidly deteriorate after being laid down.Cardiopulmonary resuscitation (cpr) was performed until a pulse was regained.Epinephrine was administered and all devices were removed from the patient.The patient was intubated which helped with stabilization, but the patient coded again.Cpr was performed with other resuscitation efforts until a pulse was regained.The patient was sent to the intensive care unit where she passed away.

• Brand Name: TRIEVER24
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): INARI MEDICAL, INC.; 6001 oak canyon; irvine CA 92618
• Manufacturer (Section G): INARI MEDICAL, INC.; 6001 oak canyon; irvine CA 92618
• Manufacturer Contact: james bennett ; 6001 oak canyon; irvine, CA 92618 ; 9493744235
• MDR Report Key: 22957420
• Report Number: 3020347218-2025-00056
• Device Sequence Number: 18243890
• Product Code: QEW
• UDI-Device Identifier: 00850291007185
• UDI-Public: 00850291007185
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/03/2025

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: 08/04/2025
• Initial Report FDA Received Date: 09/03/2025
• 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
• Outcome Attributed to Adverse Event: Death; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Female