MAUDE Adverse Event Report: INARI MEDICAL, INC. ARTIX MT THROMBECTOMY DEVICE, 4-8MM, 130CM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	32-103
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
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 patient underwent arterial thrombectomy using inari devices.The patient had preexisting, overlapping stents in their right superficial femoral artery, extending to their popliteal artery, that were placed three years prior.The patient's clot age was estimated at five days.During the thrombectomy, the artix mt thrombectomy device (artix mt8) caught on the distal end of the patient's preexisting stent and displaced the stent 3-4 centimeters.The artix mt8 was removed without issues and the physician re-lined the patient's stent with a covered stent.
Event or Problem Description
On (b)(6) 2025, a patient underwent arterial thrombectomy using inari devices.The patient had preexisting, overlapping stents in their right superficial femoral artery, extending to their popliteal artery, that were placed three years prior.The patient's clot age was estimated at five days.During the thrombectomy, the artix mt thrombectomy device (artix mt8) caught on the distal end of the patient's preexisting stent and displaced the stent 3-4 centimeters.The artix mt8 was removed without issues and the physician re-lined the patient's stent with a covered stent.
Additional Manufacturer Narrative
The artix mt thrombectomy device (artix mt8) was returned to the manufacturer and evaluated.The device was also returned with an artix mt thrombectomy device (artix mt6), an artix thin-walled sheath (artix sheath) and artix funnel catheter (funnel catheter).A clear plastic bundle was also returned with the devices.Visual inspection of the mt8 revealed fractured stent struts entangled in the coring element.Additionally, the coring element was distorted and the coring element bag struts were fully intact, confirmed via microscopic inspection.The radiopaque tip of the device was not returned for inspection.Visual inspection of the mt6 revealed fractured stent struts entangled in the coring element.No other damage or defects were observed.No external damage or defects were observed on the funnel catheter or sheath.The devices were examined under borescope and the funnel catheter exhibited shearing of the inner liner.No liner shaft wall damage was observed for the other devices.The most probable root cause for the reported stent interaction was likely the result of tracking the guidewire through a wall of a stent, leading to the mt8 interacting with a protruding edge of the patient's stent.This interaction likely created resistance when attempting to remove the device as evidenced by the distorted bag and separated radiopaque tip.The mt6 was likely passed after the mt8 and collected the broken stent struts.The sharp edges of the stent struts likely scrapped the inner funnel catheter shaft, leading to the observed liner delamination (clear plastic bundle that was returned and inner liner shearing on the funnel catheter).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 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 device labeling warns users to ¿use caution when manipulating or advancing through a stent or graft.¿ manufacturer reference number: (b)(4).

• Brand Name: ARTIX MT THROMBECTOMY DEVICE, 4-8MM, 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: 23610644
• Report Number: 3020347218-2025-00080
• Device Sequence Number: 9917852
• Product Code: QEW
• UDI-Device Identifier: 00810123710591
• UDI-Public: (01)00810123710591(17)260728(10)25070152
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 02/25/2026

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: 07/28/2026
• Device Model Number: 32-103
• Device Catalogue Number: 32-103
• Device Lot Number: 25070152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2025
• 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: Unknown