MAUDE Adverse Event Report: INARI MEDICAL, INC. CLOTTRIEVER XL CATHETER, 16FR, 105CM; 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	Stroke/CVA (1770)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices were discarded by the user facility and are not available for evaluation.The device identifiers were not provided, however, the lot history records of all potential lots shipped to the facility were reviewed and there were no discrepancies or unusual findings.The case was reviewed by the stryker peripheral vascular (pv) medical affairs team who concluded the patient likely deteriorated likely as a result of clot embolism.The device labeling lists distal embolization of blood clots as a possible adverse event/complication.The device labeling includes the following warning: "operation of a thrombectomy catheter may cause embolization of some thrombus and/or thrombotic 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)." manufacture reference number: (b)(4).
Event or Problem Description
On (b)(6) 2026 a 67-year-old patient underwent deep vein thrombosis (dvt) thrombectomy using inari devices.The patient had clot int their left lower extremity as well as their inferior vena cava (ivc).The patient also had a preexisting filter in their ivc.The patient was positioned supine to remove their ivc filter.The ivc filter was successfully removed at the start of the case using the protrieve sheath.Following the filter removal, aspiration was performed through the protrieve sheath, which removed thrombus from the patient's ivc.The protrieve sheath was then removed and the patient's neck assess site was closed and the patient was repositioned prone to continue the procedure.Four thrombectomy passes were performed using the clottriever xl catheter.After the fourth pass, the patient began to deteriorate and became unresponsive.The sheath was secured and the patient was repositioned supine.The stoke team was called and the patient was placed on a non-rebreather with oxygen at 15 liters per minute.Tenecteplase (tnk) was administered and the patient became responsive and was able to follow commands and move extremities.Following stabilization, imaging demonstrated findings consistent with a minor stroke.It was suspected that embolization of thrombus occurred during the procedure through a previously unknown patent foramen ovale (pfo).Follow up with the physician the following day indicated the patient was clinically improved.

• Brand Name: CLOTTRIEVER XL CATHETER, 16FR, 105CM
• 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 ; 9494132147
• MDR Report Key: 24475507
• Report Number: 3020347218-2026-00014
• Device Sequence Number: 9361168
• Product Code: QEW
• UDI-Device Identifier: 00850291007277
• UDI-Public: 00850291007277
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K242557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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
• Device Catalogue Number: 41-102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/27/2026
• 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: Life Threatening
• Patient Age: 67 YR
• Patient Sex: Unknown