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

Model Number	22-101
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
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 hemoptysis was the result of catheter perforation.Manufacturer reference #: (b)(4).Cardiac perforation and cardiac tamponade are identified in the labeling as possible adverse events/complications.
Event or Problem Description
A (b)(6) year-old female with pulmonary embolism underwent a thrombectomy with inari devices.The physician began by wiring to the left side.A bentson wire was used to select a vessel which ended up being a more proximal branch in the distal middle lobe.The bentson wire was swapped for an amplatz superstiff and the triever24 (t24) was advanced.Upon advancing the t24 through the heart, the physician felt that the catheter suddenly advanced forward.Imaging was performed which showed that the t24 had advanced very distal to the end of the wire.The t24 was backed out into the entrance area of the left pulmonary artery when the patient experienced hemoptysis.An angiogram revealed a vessel perforation in the wired branch.Ballooning was performed until the bleeding had stopped.The perforation was also embolized with multiple coils.The patient's condition improved on the table and follow-up revealed that the patient was doing fine.

• Brand Name: TRIEVER24
• 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: 23417084
• Report Number: 3020347218-2025-00073
• Device Sequence Number: 18749916
• Product Code: QEW
• UDI-Device Identifier: 00810123710096
• UDI-Public: (01)00810123710096(17)270618(10)25060104
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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 Model Number: 22-101
• Device Lot Number: 25060104
• 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: 10/01/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZ SUPERSTIFF 1CM TAPER WIRE; BENTSON WIRE
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Female