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

Model Number	22-101
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Pseudoaneurysm (2605); Thromboembolism (2654)
Date of Event	11/28/2023
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 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.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's chief medical officer, who concluded that the patient's pseudoaneurysm was likely the result of user error where the device was subjected to excessive force.Labeling states: "avoid using excessive force to advance or retract against resistance.If excessive resistance occurs, retract, and remove the device.Excessive force against resistance may result in damage to the device or vessel perforation." pseudoaneurysm is identified in the device labeling as potential complication(s)/adverse event(s).Manufacturer reference #: (b)(4).
Event or Problem Description
A male patient in his early 70s with a pulmonary embolism (pe) underwent a thrombectomy on (b)(6) 2023 using the inari flowtriever system.The procedure was successful, but it was noted that there was difficulty advancing the triever24 and triever16 into the pulmonary artery.Postoperatively, a computed tomography scan revealed a pseudoaneurysm in the right ventricle.A wall-adherent clot-in-transit (cit) was also observed.A second thrombectomy was attempted on (b)(6) 2023 with the inari flow triever, but the cit was unable to be aspirated.The cit was removed surgically, and the pseudoaneurysm was ligatured during the same operation.

• Brand Name: TRIEVER24
• 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: keith hebert ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 6513233614
• MDR Report Key: 18509280
• Report Number: 3020347218-2024-00002
• Device Sequence Number: 12728637
• Product Code: QEW
• UDI-Device Identifier: 00850291007185
• UDI-Public: 00850291007185
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2024

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
• 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: 12/15/2023
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 SUPER STIFF GUIDEWIRE; GORE DRY SEAL; PIGTAIL CATHETER; TRIEVER20
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male