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	07/10/2025
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 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, 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.Manufacturer reference #: (b)(4).
Event or Problem Description
A 58-year-old patient with left iliac deep vein thrombosis that extended into the inferior vena cava (ivc), underwent a thrombectomy with the clottriever xl catheter (ctxl).The patient was placed prone and expressed that they could not breath well.The patient's o2 was measured to be 89% at this time, so the procedure was continued.Due to the patient's elevated creatine levels, no computed tomography scan was performed prior to the procedure, and no contrast was used.Intravenous ultrasound was used and showed significant clot from the iliac into the ivc.No clot capture was used and the ctxl was used to perform 2 passes.Between the passes, the patient began saying they could not breathe despite their o2 being 88%.The patient was placed on a non-rebreather which helped improve their o2.However, the patient was also tachycardic and began expressing concerns over breathing again.The patient also began to push himself up from the table.The patient was flipped over but during this process, the patient's heart rate dropped and stopped.Cardiopulmonary resuscitation was performed for 40 minutes but unfortunately, a pulse was never regained.

• 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: 22745205
• Report Number: 3020347218-2025-00050
• Device Sequence Number: 15580114
• Product Code: QEW
• UDI-Device Identifier: 00850291007277
• UDI-Public: (01)00850291007277(17)260827(10)24080148
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/07/2025

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: 08/27/2026
• Device Model Number: 41-102
• Device Lot Number: 24080148
• 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: 07/10/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2024
• 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
• Outcome Attributed to Adverse Event: Death; Life Threatening
• Patient Age: 58 YR
• Patient Sex: Unknown