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

Model Number	21-101
Medical Device Problem Codes	Retraction Problem (1536); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent deep vein thrombosis (dvt) thrombectomy using inari devices.The patient's clot age was estimated at 14 days.When attempting to remove the triever 20 after the final aspiration, the catheter became stuck in the patient's vessel.Following multiple attempts to remove the device using ballooning and medication, the device separated and approximately 10-15cm of the catheter remained in the patient.The medical team was unsuccessful in removing the remaining part of the catheter during the procedure, however; the medical team was able to remove the piece of the device the following day.
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.Manufacturer reference: (b)(4).
Additional Manufacturer Narrative
The triever20 (t20) was returned to the manufacturer and evaluated.Visual inspection of the device confirmed the device was separated near the distal end of the catheter and a section of the coil was exposed and unraveled.The catheter separated likely due to excessive force used to advance or retract the device against resistance, likely after the patient experienced a vasospasm.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 statement: "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." 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: james bennett ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 8779234747
• MDR Report Key: 22375105
• Report Number: 3020347218-2025-00042
• Device Sequence Number: 15476720
• Product Code: QEW
• UDI-Device Identifier: 00810123710065
• UDI-Public: (01)00810123710065(17)270109(10)25010064
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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 Model Number: 21-101
• Device Lot Number: 25010064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FLOWSAVER; TRIEVER16
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown