MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER20; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	21-101
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a 49-year-old male underwent deep vein thrombosis (dvt) thrombectomy using inari devices.The patient's clot age was estimated at 90 days.During the thrombectomy, the treiver20 catheter (t20) was advanced without an introducer sheath into the left popliteal vein.An aspiration was performed, and the catheter was retracted.The tip of the catheter became stuck while retracting the catheter through the common iliac vein.The catheter was retracted a few more inches and then fractured.Half of the catheter and the dilator were removed and approximately 20 centimeters of the t20 delivery catheter remained in the patient's vessel.Scissors were used to cut the wire braiding of the t20.An intri24 introducer sheath (intri24) was then advanced to where the tip was just over the proximal (broken) end of the t20 and a 10x40 balloon was placed over the wire at the distal end of the remaining portion of the t20 catheter into the intri24.The intri24, t20 catheter, and balloon were then removed together and the intri24 was flushed and replaced into the left popliteal vein.All material was confirmed to be removed from the patient and the patient sustained no injuries.The patient remained stable throughout the procedure and the case was completed without further issues.
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.Upon completion of the investigation, a follow-up report will be submitted.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 the flowtriever catheter or triever20 against resistance.If excessive resistance occurs, retract and remove the device.Excessive force against resistance may result in damage to the device or vessel perforation." the device labeling recommends using a 22 fr introducer sheath while using the flowtriever system.Manufacturer reference: (b)(4).
Additional Manufacturer Narrative
The treiver20 (t20) was returned to the manufacturer and evaluated.Visual inspection of the device confirmed the catheter had completely separated and the distal tip of the catheter was severely crumpled.The separation was approximately 13 inches from the distal tip, which aligns with the 45d pebax and 72d pebax segments, which is also where the coil and brain overlap.A dimensional inspection of the separated catheter was not feasible due to the shear condition of the catheter at the failure site.Review of pebax 45d, pebax 72d, and pfte liner were reviewed and no non-conformities or deviations from the specified material tolerances were identified during the inspection of these components.Additionally, review of the manufacturing lot revealed no anomalies or discrepancies in the assembly process that could have contributed to the observed failure.Based on the investigation, the most likely cause of the separation was due to procedural factors such as excessive manipulation during the procedure and excessive force used to advance or retract the device against resistance.The absence of an introducer sheath likely exasperated the force needed to advance or retract the device.Manufacturer reference: (b)(4).

• Brand Name: TRIEVER20
• 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: 21520940
• Report Number: 3020347218-2025-00015
• Device Sequence Number: 9618761
• Product Code: QEW
• UDI-Device Identifier: 00810123710065
• UDI-Public: (01)00810123710065(17)260702(10)24070012
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K213402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: 07/02/2026
• Device Model Number: 21-101
• Device Lot Number: 24070012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 154 KG