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

Model Number	32-103
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	03/04/2025
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 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 injury was the result of inadvertent catheter perforation.The device labeling includes the following warning statements: "avoid using excessive force to advance or retract against resistance.If excessive resistance occurs, retract, and collapse the self-expanding element into the catheter and remove the device.Excessive force against resistance may result in damage to the device or vessel perforation." the device labeling includes the following contraindications: "not intended for removal of fibrous, adherent, or calcified material (e.G., atherosclerotic plaque)." perforation of pulmonary arteries is listed as a potential complication/adverse event.Manufacturer reference #: (b)(6).
Event or Problem Description
A (b)(6) female underwent a thrombectomy with the inari artix system.Four passes were performed but a perforation occurred in the distal superficial femoral artery.It is speculated that the artix mt8 went through a calcified section.A viabahn stent was used to cover the injury, and the patient experienced no other side effects.The procedure was completed successfully.

• Brand Name: ARTIX MT
• 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, CA 92618 ; 9494132147
• MDR Report Key: 21757397
• Report Number: 3020347218-2025-00025
• Device Sequence Number: 13217030
• Product Code: QEW
• UDI-Device Identifier: 00810123710591
• UDI-Public: (01)00810123710591(17)250320(10)24090087
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K241894
• 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): 04/02/2025

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 Expiration Date: 03/20/2025
• Device Model Number: 32-103
• Device Lot Number: 24090087
• 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: 03/04/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2024
• 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: 5MM SPIDER WIRE; 65 CM SHEATH AND FLOW ARREST FUNNEL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female