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

Model Number	41-102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	07/22/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The inari devices were discarded by the user facility and are not available for evaluation.The device identifiers were not provided, the lot history records of all potential lots shipped to the facility 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, design, or labeling.The case was reviewed by inari stryker medical affairs, who concluded that the patient's death was potentially the result of inadvertent clot embolism.Distal embolization of blood clots is identified in the device labeling as possible adverse events/complications.The device labeling also lists the following warning: "operation of a thrombectomy catheter may cause embolization of some thrombus and/or thrombus particulate, physician discretion advised.The potential for extensive and/or difficult to treat pulmonary thromboembolism should be carefully considered when clottriever xl catheter is used to engage and remove thrombus from large vessels such as the inferior vena cava (ivc)." manufacturer reference #:(b)(4).
Event or Problem Description
A patient with pulmonary embolism and their inferior vena cava (ivc) completely occluded with thrombus was admitted to the hospital and underwent a thrombectomy.There was some clot in the left pulmonary artery, but the physician opted to go after the ivc clot first.Multiple aspirations were performed unsuccessfully.A pass was done with the clottriever xl catheter which returned a bag full of chronic clot and/or tumor thrombus.However, once the catheter pulled, the patient immediately deteriorated.Unfortunately, the patient ultimately expired.

• Brand Name: CLOTTRIEVER XL CATHETER
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): INARI MEDICAL, INC.; 6001 oak canyon; irvine CA 92618
• Manufacturer (Section G): INARI MEDICAL, INC.; 6001 oak canyon; irvine CA 92618
• Manufacturer Contact: james bennett ; 6001 oak canyon; irvine, CA 92618 ; 9493744235
• MDR Report Key: 22856443
• Report Number: 3020347218-2025-00054
• Device Sequence Number: 9202917
• Product Code: QEW
• UDI-Device Identifier: 00850291007277
• UDI-Public: 00850291007277
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/20/2025

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 Model Number: 41-102
• 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: 07/22/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Death; Life Threatening
• Patient Sex: Unknown