MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER16; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	25-101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Chest Pain (1776); Hemoptysis (1887); Great Vessel Perforation (2152); Cardiac Perforation (2513); Intraoperative Pain (2662); Asystole (4442)
Date of Event	09/04/2023
Type of Reportable Event	Death
Event or Problem Description
A 72-year-old female underwent attempted thrombectomy with the inari flowtriever system due to preexisting bilateral pulmonary embolism (pe).The patient had a hip fracture and surgery one month prior to the thrombectomy and presented as an intermediate-high risk patient.During an aspiration with the triever16, the patient experienced an acute onset of chest pain and massive hemoptysis.The patient rapidly progressed to asystolic cardiac arrest.Angiography was performed which revealed perforation of the distal segment of the left main pulmonary artery.Occlusion of the proximal artery was performed with a balloon and selective intubation was performed to exclude the left pulmonary artery and main bronchus.Advanced cardiac life support was performed for 40 minutes, but efforts were not successful in obtaining spontaneous circulation and unfortunately the patient expired.
Additional Manufacturer Narrative
The inari device was discarded by the user facility and was 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 inadvertent cardiac perforation.Cardiac perforation, vessel dissection/perforation, cardiogenic shock, and death are listed in the device labeling as potential complications / adverse events.Manufacturer reference #: (b)(4).

• Brand Name: TRIEVER16
• 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: kit cariquitan ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 8779234747
• MDR Report Key: 17750495
• Report Number: 3020347218-2023-00016
• Device Sequence Number: 7094360
• Product Code: QEW
• UDI-Device Identifier: 00850291007130
• UDI-Public: 00850291007130
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K211013
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2023

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: 11/21/2024
• Device Model Number: 25-101
• Device Lot Number: 22110090
• 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: Not provided
• Initial Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• 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: AMPLATZ SUPER STIFF 1CM TIP FLOPPY.
• Outcome Attributed to Adverse Event: Death; Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female