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

Model Number	42-102
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	12/30/2024
Type of Reportable Event	Death
Event or Problem Description
The patient was a 27-year-old male with deep vein thrombosis.The majority of the patient's thrombus had been removed using a triever20.Imaging was performed which revealed residual clots the physician chose to address with the clottriever xl catheter (ctxl).No inferior vena cava (ivc) filter or protection was seen.The ctxl was used to perform a pass in the common femoral vein.After removal and cleaning the basket, the patient's o2 dropped to the low 90s.After a couple of deep breaths, the patient's o2 came back up, and the physician performed another pass.After this occurred, the patient's o2 dropped again but more significantly.A code was called, and the patient was flipped onto his stretcher.Multiple rounds of resuscitation medications were administered to the patient.Resuscitation efforts (cpr) were continued for 45 minutes before the case was called and the patient expired.
Additional Manufacturer Narrative
The inari 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.There was no report of any device malfunction.Based on the information reviewed, there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, or design.The case was reviewed by inari's chief medical officer, who concluded that the patient's death was the result of inadvertent clot embolism.Distal embolization of blood clots is identified in the device labeling as possible adverse events/complications.Manufacturer reference #: (b)(4).

• Brand Name: CLOTTRIEVER XL CATHETER
• 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 ; 9494132147
• MDR Report Key: 21266451
• Report Number: 3020347218-2025-00005
• Device Sequence Number: 3664733
• Product Code: QEW
• UDI-Device Identifier: 00850291007277
• UDI-Public: (01)00850291007277(17)251129(10)23110115
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K242557
• 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
• Report Date (Section B): 01/29/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2025
• Device Model Number: 42-102
• Device Lot Number: 23110115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FLOWSAVER; TRIEVER20
• Outcome Attributed to Adverse Event: Death; Required Intervention; Life Threatening
• Patient Age: 27 YR
• Patient Sex: Male