MAUDE Adverse Event Report: INARI MEDICAL, INC. LIMFLOW EXTENSION STENT GRAFT, 5.5MM X 200MM; STENT GRAFT, INFRAPOPLITEAL, VENOUS ARTERIALIZATION

Model Number	RGS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer reference number: (b)(4).The device has been returned to the manufacturer for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2026, a patient underwent a procedure using the limflow system of devices.The procedure progressed successfully to stent deployment.Afterward it was found that a piece of the catheter had broken off into the patient.The surgeon was able to remove it and completed the case.

• Brand Name: LIMFLOW EXTENSION STENT GRAFT, 5.5MM X 200MM
• Common Device Name: STENT GRAFT, INFRAPOPLITEAL, VENOUS ARTERIALIZATION
• Manufacturer (Section D): INARI MEDICAL, INC.; 6001 oak canyon; suite 100; irvine CA 92618
• Manufacturer (Section G): CONFLUENT MEDICAL TECHNOLOGIES INC.; coyol free zone; building 28; alajuela 20113 ; CS 20113
• Manufacturer Contact: james bennett ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 9494132147
• MDR Report Key: 25114198
• Report Number: 3023527320-2026-00001
• Device Sequence Number: 18706831
• Product Code: QWN
• UDI-Device Identifier: 00850041730219
• UDI-Public: (01)00850041730219(17)260714(10)82343334
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 06/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2026
• Device Model Number: RGS
• Device Catalogue Number: RGS-55200-US-24
• Device Lot Number: 82343334
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2025
• 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