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

Model Number	RGS
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent transcatheter arterialization of deep vein (tadv) using limflow devices.The limflow extension stent graft, 200mm (rgs-55200-us-24) partially deployed a stent, requiring the physician to disassemble the device handle and finish the deployment manually.This did not result in any patient harm and the procedure was successful.
Additional Manufacturer Narrative
The limflow devices were discarded by the user facility and are 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 instruction: "5.Ensure the delivery system is pinned to a flat surface and is as straight as possible out of the femoral sheath.Caution: any slack in the stent system (outside the patient) could result in deployment challenges." manufacturer reference number: (b)(4).

• Brand Name: LIMFLOW EXTENSION STENT GRAFT, 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: 23709322
• Report Number: 3023527320-2025-00007
• Device Sequence Number: 18823080
• Product Code: QWN
• UDI-Device Identifier: 00850041730219
• UDI-Public: (01)00850041730219(17)260624(10)82342297
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P220025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 12/03/2025

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: 06/06/2026
• Device Model Number: RGS
• Device Catalogue Number: RGS-55200-US-24
• Device Lot Number: 82342297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2025
• 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
• Patient Sex: Unknown