MAUDE Adverse Event Report: INARI MEDICAL, INC. ARTIX MT THROMBECTOMY DEVICE, 3-6MM, 130CM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	32-102
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.Upon completion of the investigation, a follow-up report will be submitted.Manufacturer reference number (b)(4).
Event or Problem Description
On (b)(6) 2025, a male patient underwent arterial thrombectomy using inari devices.The patient had a preexisting stent in his posterior tibial artery.During the thrombectomy, the artix mt thrombectomy device (mt6) caught on the patient's preexisting stent at an area of overlap.The physician attempted to resheath the mt6 and push the device forward; however, the device was only able to partially resheath and was unable to move forward.The physician then attempted to oversheath the device with a larger sheath but was also unsuccessful.The mt6 was eventually removed, however the patient's preexisting stent was fractured.As a result of the fractured stent, the medical team considered a below the knee amputation as a potential next step.Whether an amputation was carried out was not reported.
Additional Manufacturer Narrative
The artix mechanical thrombectomy device (mt6) was returned and evaluated.Visual inspection revealed a piece of a stent tangled in the mt6 element.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.Additionally, a complaint history review was conducted and no similar issues have been reported against this lot number.The mt6 most likely caught on the patient's stent due to excessive force used during retraction of the mt6 through the stent.The device labeling includes the following precaution: "use caution when manipulating or advancing through a stent or graft." the device labeling includes the following warnings: "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." "never advance or torque the artix mt against resistance without careful assessment of cause of resistance using fluoroscopy." the manufacturer's reference number: (b)(4).
Event or Problem Description
On (b)(6) 2025, a male patient underwent arterial thrombectomy using inari devices.The patient had a preexisting stent in his posterior tibial artery.During the thrombectomy, the artix mt thrombectomy device (mt6) caught on the patient's preexisting stent at an area of overlap.The physician attempted to resheath the mt6 and push the device forward; however, the device was only able to partially resheath and was unable to move forward.The physician then attempted to oversheath the device with a larger sheath but was also unsuccessful.The mt6 was eventually removed, however the patient's preexisting stent was fractured.As a result of the fractured stent, the medical team considered a below the knee amputation as a potential next step.Whether an amputation was carried out was not reported.

• Brand Name: ARTIX MT THROMBECTOMY DEVICE, 3-6MM, 130CM
• 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 ; 9494132147
• MDR Report Key: 23623744
• Report Number: 3020347218-2025-00082
• Device Sequence Number: 8968398
• Product Code: QEW
• UDI-Device Identifier: 00810123710584
• UDI-Public: (01)00810123710584(17)260806(10)25080021
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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 Expiration Date: 08/06/2026
• Device Model Number: 32-102
• Device Catalogue Number: 32-102
• Device Lot Number: 25080021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male