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

Model Number	22-101
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On july 23, 2024, a patient with pulmonary embolism (pe) underwent pe thrombectomy using inari devices.During the procedure, the treiver24 (t24) catheter was used to aspirate clot from the patient's lungs.During one aspiration in the left pulmonary artery, the distal marker band detached from the catheter but remained on the guidewire.The physician successfully aspirated the marker band though the t24.The procedure was completed with approximately 95% of thrombus removed.Postoperatively, the patient was doing very well with significant hemodynamic improvement.
Additional Manufacturer Narrative
The device was discarded by the user facility and is not available for evaluation.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.The device labeling includes foreign body embolism as a possible adverse event/complication.Manufacturer reference #: (b)(4).

• Brand Name: TRIEVER24
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): INARI MEDICAL, INC.; 6001 oak canyon; suite 100; irvine CA 92816
• Manufacturer (Section G): INARI MEDICAL, INC.; 6001 oak canyon; suite 100; irvine CA 92816
• Manufacturer Contact: keith hebert ; 6001 oak canyon; suite 100; irvine, CA 92816 ; 6513233614
• MDR Report Key: 20053156
• Report Number: 3020347218-2024-00038
• Device Sequence Number: 20827559
• Product Code: QEW
• UDI-Device Identifier: 00850291007185
• UDI-Public: 00850291007185
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2026
• Device Model Number: 22-101
• Device Lot Number: 24030017
• 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: 07/24/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2024
• 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
• Patient Sex: Unknown