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

Model Number	22-101
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Chest Pain (1776); Hemoptysis (1887); Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513)
Date of Event	10/09/2023
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 the result of catheter perforation due to wire positioning.Cardiac perforation, vessel dissection/perforation, cardiac injury, cardiogenic shock, clinical deterioration, and death are listed in the device labeling as potential complications / adverse events.Manufacturer reference #: (b)(4).
Event or Problem Description
The patient was admitted to the intensive care unit (icu) for treatment of a bilateral central pulmonary embolism (pe) with positive biomarkers and right heart strain.The patient deteriorated slightly under medical anticoagulation therapy; due to her medical history it became apparent that the clot was greater than 10 days old and thrombolytics may not be effective.The decision was made to perform a thrombectomy with the inari flowtriever system.The patient was stable upon arrival at the cardiac catheterization lab.Wire positioning was obtained in the left pulmonary artery and the triever24 (t24) catheter was advanced without issue.The first and second aspirations filled the syringe slowly and steadily, but no clot was observed.During the third aspiration the double vacuum technique was used and the t24 was repositioned into the left main trunk and the syringe filled rapidly, but again no clot was retrieved.The decision was made to advance the t24 with the dilator and perform another aspiration in the interlobar artery.When the t24 was advanced, the patient's blood pressure decreased below 100 mmhg (systolic) for approximately 15 seconds before improving.The first and second aspirations in this new position resulted in cavitation.As the syringe did not fill, the t24 was repositioned to the left main pulmonary trunk.Another vacuum was applied and the t24 was pulled back into the pulmonary trunk when the patient reported experiencing chest pain.The patient began coughing with sudden onset of massive hemoptysis.This was followed by a decrease in heart rate, oxygenation, and blood pressure.The patient arrested, a code was initiated, and cardiopulmonary resuscitation (cpr) was administered along with supra and prothrombin.Attempts were made to block the left pulmonary artery, but no improvements in hemodynamics were observed.Multiple other resuscitation efforts were attempted without return of spontaneous circulation.The decision was made to stop cpr after 60 minutes and 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: 18088363
• Report Number: 3020347218-2023-00019
• Device Sequence Number: 17823987
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2023

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: 04/14/2025
• Device Model Number: 22-101
• Device Lot Number: 23040064
• 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: 10/09/2023
• Initial Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2023
• 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: 260 CM J TYPE STANDARD WIRE; 8 FR SHEATH; ANGLED PIGTAIL CATHETER; BSCI AMPLATZ SS 1 CM
• Outcome Attributed to Adverse Event: Death; Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female