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

Model Number	32-102
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	10/09/2025
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 not provided, however, the lot history records of all potential lots shipped to the facility were reviewed and there were no discrepancies or unusual findings.The case was reviewed by inari stryker medical affairs, who concluded that the device became caught in the patient's preexisting stent was likely the result of user error and the device separated likely due to user error (using excessive force).The device labeling includes the following warning statement: "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 precaution statement: "use caution when manipulating or advancing through a stent or graft." manufacturer reference #:(b)(4).
Event or Problem Description
On (b)(6) , 2025, an (b)(6) -year-old male patient underwent arterial thrombectomy using inari devices.The patient had a stent implanted in his right popliteal artery two weeks prior to the thrombectomy.During the procedure, the artix mechanical thrombectomy device (mt6) became caught on the distal part of the stent when pulling the mt6 through the stent.The physician tried to back the device out; however, it would not retract.The patient was transferred to the cardiovascular operating room, and the surgeon accessed the popliteal artery below the stent.The stent and the artix mt6, which separated at the distal end, were removed through the artix thin-walled sheath and out of the patient's leg.

• 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: james bennett ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 8779234747
• MDR Report Key: 23418579
• Report Number: 3020347218-2025-00074
• Device Sequence Number: 21399815
• Product Code: QEW
• UDI-Device Identifier: 00810123710584
• UDI-Public: 00810123710584
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 32-102
• 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: 10/09/2025
• Initial Report FDA Received Date: 10/29/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARTIX THIN-WALLED SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male