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

Model Number	32-102
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The artix mechanical thrombectomy device (mt6) was returned to the manufacturer for evaluation.The device was observed under magnification.No damage was observed on the element's struts.A loose, bent platinum wire was observed.During retraction of the mt6, the coring element caught on the proximal portion of the stent, which caused the pieces of the stent to sheer off.The initial resistance during retraction of the device likely caused the broken pieces of the stent.The loose bent platinum wire observed on the element was likely caused when the element caught on the stent.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 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, a male patient underwent arterial thrombectomy using inari devices.The patient's clot age was estimated to be 17 days old.The patient had a preexisting stent (less than one year old) in his right superficial femoral artery.During the thrombectomy, the artix mechanical thrombectomy device (mt6) became caught in the proximal portion of the patient's preexisting stent, which resulted in the stent breaking and getting stuck on the mt6.The entire stent migrated proximal to the artery.The mt6 and artix covered funnel catheter were removed together.The patient's artery was relined with a new stent and the procedure was terminated.

• 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: mazi kiani ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 8779234747
• MDR Report Key: 22652167
• Report Number: 3020347218-2025-00048
• Device Sequence Number: 8828133
• Product Code: QEW
• UDI-Device Identifier: 00810123710584
• UDI-Public: (01)00810123710584(17)251101(10)24100184R
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

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 Expiration Date: 11/01/2025
• Device Model Number: 32-102
• Device Lot Number: 24100184R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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