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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer refence number: (b)(4).The suspect device will not be returned to the manufacturer.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.Evaluation of this adverse event by the stryker medical affairs team concluded that the patient required an arterial cutdown due to the mt8 being overfilled with clot.
Event or Problem Description
On (b)(6) 2026, a patient underwent a thrombectomy procedure using the artix system of devices.The patient had a left side fem-pop bypass graft that contained clot that had required prior treatment.Right cfa access obtained and the introducer sheath placed.Imaging taken noted that the entire graft was full of clot.The stryker 65cm sheath was prepped and placed in left cfa.The wire was exchanged for a spider wire/filter 0.014 wire with filter proximal to popiteal artery.The funnel sheath was prepped and funnel placed within 2cm nub of graft to protect the profunda artery.The artix mt sheath was prepped based on sizing of graft at 8mm diameter.Multiple passes were performed, yielding acute, subacute and chronic clot.The decision was made to angioplasty the graft and re-apply remaining clot to sides of graft.The funnel catheter was re-captured under aspiration.During mechanical passes the mechanical element had decent resistance come mid graft.It was identified that a small clot maneuvered into the peroneal artery.We removed the spider wire, wired the peroneal and ballooned the peroneal and achieved patency.We also wired the hibernating pt and at and opened those arteries so patient now had 3 vessel runoff.Our last effort was now to re-deploy the funnel catheter and capture last large clot.The clot was captured but could not be pulled through funnel catheter/sheath.All attempts were futile, resulting in the surgeon to resort to a lcfa cutdown to remove the clot.It was a heavily organized 6mm diameter clot that we were trying to pull through a 2.6mm sheath.

• 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: 24689936
• Report Number: 3020347218-2026-00028
• Device Sequence Number: 9653041
• Product Code: QEW
• UDI-Device Identifier: 00810123710591
• UDI-Public: (01)00810123710591(17)260728(10)25070143
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 03/25/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2026
• Device Model Number: 32-103
• Device Catalogue Number: 32-103
• Device Lot Number: 25070143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female