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); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
On (b)(6) 2025, a 47-year-old female underwent a deep vein thrombosis (dvt) thrombectomy using inari devices.The patient had a preexisting inferior vena cava (ivc) filter.The patient's clot age was estimated at 100 days.During the thrombectomy, the treiver20 catheter (t20) was advanced without an introducer sheath into the right popliteal vein to target clot in the right femoral vein.While trying to move the catheter within the vessel, the catheter became stuck and would not advance or retract.The catheter then separated, leaving the two halves connected by the inner coil.An attempt was made to remove the catheter using a mustang balloon; however, the attempt was unsuccessful.After two doses of nitroglycerin were administered, the physician was able to remove the catheter in full by twisting it clockwise.There were no injuries to the patient.
Additional Manufacturer Narrative
The treiver20 (t20) was returned to the manufacturer and evaluated.Visual inspection confirmed a clear material separation at the material joint (35d-45d), the transition between the high and low durometer materials.To assess the material's integrity, durometer consistency was tested, and ft-ir spectra were obtained to identify any chemical changes potentially caused by over-processing, which could affect mechanical properties.The results showed no significant signs of chemical or mechanical instability.Additionally, thermogravimetric analysis (tga) was conducted to evaluate potential thermal degradation from over-processing.No evidence of degradation was found.Further analysis of the failure site was performed using a scanning electron microscope (sem) to determine whether the fracture exhibited brittle or ductile characteristics.Sem imaging at approximately 1.5 kx magnification revealed a fracture pattern consistent with brittle failure, likely attributed to the geometry of the structure.No signs of micro-ductility were observed.The brittleness of the material at the break in combination with not using an introducer sheath likely caused the failure.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: 21380045
• Report Number: 3020347218-2025-00011
• Device Sequence Number: 8462038
• Product Code: QEW
• UDI-Device Identifier: 00850291007079
• UDI-Public: (01)00850291007079(17)250727(10)23070090
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/20/2025

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: 01/27/2025
• Device Model Number: 21-101
• Device Lot Number: 23070090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 50 KG