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	04/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The artix mechanical thrombectomy device (mt6) was returned to the manufacturer for evaluation with the broken stent pieces.The mt6 was observed under 20x magnification and found no damage on the struts or wire of the mt6 element.The damage to the patient's stents was likely caused by excessive force used during retracting of the mt6 through the long segmented stent.During retraction, the mt6 element was caught on the stent and then was resheathed back into the delivery catheter before removal of the device.The initial resistance during retraction most likely caused the broken pieces of the stent which were retrieved during reshaeathing.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 statements: "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." manufacturer reference #: (b)(4).
Event or Problem Description
On (b)(6) 2025, a 62-year-old male underwent arterial thrombectomy using inari devices.The patient had preexisting stents in the right superficial femoral and right popliteal arteries.During the thrombectomy, the artix mechanical thrombectomy device (mt6) was advanced inside a long segment stent and clot was removed.The next pass, the mt6 was advanced more distal through the long stented segment and when the device was removed from the patient, the mt6 became stuck on one of the pre-existing stents.The doctor resheathed the mt6 inside the stent and when the device was removed, it was noted two pieces of the stent were removed as well.The medical team used an artix ax aspiration catheter to complete the case.Stenting was done after the thrombectomy, and full flow was restored post thrombectomy.

• 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 ; 6513233614
• MDR Report Key: 22057382
• Report Number: 3020347218-2025-00032
• Device Sequence Number: 8328860
• Product Code: QEW
• UDI-Device Identifier: 00810123710584
• UDI-Public: (01)00810123710584(17)250804(10)25020013
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2025

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: 08/04/2025
• Device Model Number: 32-102
• Device Lot Number: 25020013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2025
• 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 AX ASPIRATION CATHETER.; ARTIX THIN-WALLED SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 91 KG