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 or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The inari devices were 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 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 includes the following precaution: "use caution when manipulating or advancing through a stent or graft." manufacturer reference number (b)(4).
Event or Problem Description
On (b)(6) 2026, a patient underwent an arterial thrombectomy using inari devices.The patient had preexisting stents in their right superficial femoral artery (sfa) placed three months prior and the patient's right leg was no longer functional.Visual inspection of the stents using angiography and fluoroscopy revealed the stents were overlapping and stented most of the patient's sfa.There was no blood flow observed inside of the patient's stents.The artix thin-walled sheath (artix sheath) was placed and the artix mechanical thrombectomy device (mt8) was advanced through the artix sheath to the mid sfa.Clot was removed after one pass with the mt8 and no noted stent interaction occurred.Eight more passes were completed and an angiogram revealed limited flow through the stented area.The medical team then attempted to complete a pass from the middle of the stent where resistance was met and extra force was used to retract the mt8.Under fluoroscopy, the medical team visualized the middle stent migrated into the proximal stent and noticed metal poking out of the mt8 coring element when the device was removed.With further assessment, the metal piece appeared to be a part of the patient's preexisting stent.Balloons were expanded in the stented area with no issues observed.Additional stents were placed and as a result of the new stents and ballooning, full blood flow was seen to the area and there was no harm to the patient.During a follow up discussion with the physician two days following the procedure, the physician reported the patient was doing well.

• 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: 24218118
• Report Number: 3020347218-2026-00005
• Device Sequence Number: 8224663
• Product Code: QEW
• UDI-Device Identifier: 00810123710591
• UDI-Public: (01)00810123710591(17)260925(10)25090143
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/29/2026

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: 09/25/2026
• Device Model Number: 32-103
• Device Catalogue Number: 32-103
• Device Lot Number: 25090143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2025
• 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 Sex: Unknown