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

Model Number	32-103
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	09/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient underwent arterial thrombectomy using inari devices.The patient had undergone a percutaneous transmural arterial bypass (ptab) one week prior.The patient had a preexisting stent in the left superficial and left popliteal arteries and a bypass graft in the left superficial artery.The patient had clot in their left popliteal and left superficial femoral arteries.The patient's clot age was estimated at four days.Two successful passes were completed using the artix mechanical thrombectomy device (mt8) then during the third pass, the mt8 became caught on the patient's preexisting stent and significant resistance was felt when trying to retract the device.The physician used significant force to remove the mt8 and upon removal, the artix coring element had separated from the catheter and remained in the patient's vessel.An endarterectomy was performed which successfully removed the mt8 coring element and the patient's proximal preexisting stent.The patient was doing well post-endarterectomy and did not require any additional medical intervention.
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.Additionally, a complaint history review was conducted and no similar issues have been reported against this lot number.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).

• 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: 23363780
• Report Number: 3020347218-2025-00069
• Device Sequence Number: 9118358
• Product Code: QEW
• UDI-Device Identifier: 00810123710591
• UDI-Public: (01)00810123710591(17)260616(10)25060087
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 10/22/2025

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 Expiration Date: 06/16/2026
• Device Model Number: 32-103
• Device Lot Number: 25060087
• 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: 09/23/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARTIX COVERED FUNNEL CATHETER; ARTIX THIN-WALLED SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown