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 Codes	Cardiac Arrest (1762); Hypoxia (1918); Great Vessel Perforation (2152)
Date of Event	06/28/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The inari devices were discarded by the user facility and are not available for evaluation.The device identifiers were provided, and the lot history records 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 death was possibly the result of an inadvertent catheter perforation.Hemoptysis, hypoxemia, hypotension, vessel dissection/perforation, cardiogenic shock, clinical deterioration, and death are listed in the device labeling as potential complications / adverse events.
Event or Problem Description
A 72-year-old male with intermediate high-risk pulmonary embolism (pe) underwent a thrombectomy with the inari flowtriever system.The patient was admitted to the hospital with symptoms of dyspnea.The patient was treated with anticoagulation for a day prior to the procedure.A computed tomography angiography (cta) was performed which revealed large thrombus formations in the left and right pulmonary arteries.The patient also had elevated troponin levels with an enlarged right atrium (ra) and right ventricle (rv).Additionally, the patient's right ventricle/left ventricle ratio was larger than 1.4.The procedure began with access gained from the right common femoral vein.Obtaining wire positioning was difficult due to the patient's enlarged rv and ra, but eventually an amplatz super stiff guidewire was placed in a deep position.There was no slack in the rv, so a triever16 (t16) was used to stabilize a triever24 (t24) and advance it to the rv.An initial aspiration was performed with the t16 which removed some unorganized clot.The t16 was removed, and a triever20 curve (t20c) was used to aspirate more thrombus in the right interlobar artery.This resulted in the patient experiencing an increase in spo2 and decrease in heart rate.The t24 was advanced behind the pulmonary valve and the left pulmonary artery was wired with a jr4 catheter and j wire in a buddy wire technique.The amplatz super stiff guidewire was inserted via the jr4 catheter.However, during advancement of the t24 with t20c, the patient complained of chest pain and fainted.The patient immediately decompensated, and a pericardial tamponade was confirmed by echocardiography.The patient was intubated and pericardiocentesis was performed.Cardiopulmonary resuscitation was also administered.A thoracic surgeon was called, and a sternotomy was performed.The surgeon visually confirmed the tamponade but was unable to stop the bleeding.The patient had a "do not resuscitate" on file and intervention was halted, unfortunately the patient expired.

• 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: keith hebert ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 6513233614
• MDR Report Key: 19843047
• Report Number: 3020347218-2024-00033
• Device Sequence Number: 6647818
• Product Code: QEW
• UDI-Device Identifier: 00850291007185
• UDI-Public: 00850291007185
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/26/2024

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 Expiration Date: 03/15/2026
• Device Model Number: 22-101
• Device Lot Number: 24030058
• 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: 06/28/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• 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: AMPLATZ SUPER STIFF GUIDEWIRE; J WIRE; JR4 CATHETER; TRIEVER16
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Death
• Patient Age: 72 YR
• Patient Sex: Male