MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER24, 24FR, 90CM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	22-101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	03/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, an 85-year-old female patient underwent a thrombectomy procedure using the flowtriever system of devices.The procedure advanced through 4 aspirations of clot this no issue.The physician began crossing to the right when the patient started screaming.A stroke team and ed was called and confirmed stroke.
Additional Manufacturer Narrative
Manufacturer reference number: (b)(4).The suspect device was not returned to the manufacturer and, and as such, an evaluation could not be completed.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 stryker peripheral vascular medial affairs team determined that the available information does not allow us to rule out the possibility that the triever24 may have caused or contributed to the patient's stroke.The device labeling lists stroke as a possible adverse event/complication.

• Brand Name: TRIEVER24, 24FR, 90CM
• 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: 24874087
• Report Number: 3020347218-2026-00033
• Device Sequence Number: 10002330
• Product Code: QEW
• UDI-Device Identifier: 00810123710096
• UDI-Public: (01)00810123710096(17)270324(10)25030091
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2026

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: 22-101
• Device Catalogue Number: 22-101
• Device Lot Number: 25030091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Female