MAUDE Adverse Event Report: INARI MEDICAL, INC. FLOWTRIEVER 2 CATHETER, M; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	11-102
Medical Device Problem Codes	Entrapment of Device (1212); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The inari flowtriever2 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.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.Foreign body embolism is listed in the device labeling as potential complications / adverse events.Manufacturer reference #: (b)(4).
Event or Problem Description
A female patient with recurrent deep vein thrombosis (dvt) symptoms underwent a thrombectomy procedure with the inari triever20 (t20) and flowtriever2 (ft2) catheter in the left leg on (b)(6) 2023.Two weeks prior to this procedure, the patient had undergone a thrombectomy with a penumbra system and was stented with an ivc stent after the case was completed.The patient became symptomatic again one day prior to undergoing the inari thrombectomy procedure.Access was achieved in the left femoral vein and clot was aspirated using the triever20.There was an aneurysmal section of the stent on the medial side of the iliac vein with clot present; an ft2 catheter was used to address this clot.Two passes were performed successfully with the ft2 with aspirations from the t20.After several ivus with contrast runs were performed, the surgeon decided to attempt a third pass.During this attempt, the ft2 expandable (mesh) element became stuck in the same segment where the clot was present.Another surgeon was called in and after consultation, the surgeon severed the implanted stent in half and used an endurant ii medtronic stent to cover the dissected stent and the segment with the small ft2 element in it.A medtronic abre stent was also placed in the ivc for additional coverage.Although the fractured stent and ft2 element were unable to be retrieved from the vessel, surgical intervention was performed to use a covered stent.In addition, the inari thrombectomy procedure was successful in removing 90% of the clot, there was good outflow, and the patient made a complete recovery with resolution of dvt symptoms.In follow up discussions, the physician indicated they should have taken an x-ray prior to the procedure to better identify the condition of the stent prior to treatment.This would have revealed that the stent was fractured prior to ft2 insertion.

• Brand Name: FLOWTRIEVER 2 CATHETER, M
• 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: kit cariquitan ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 8779234747
• MDR Report Key: 17242856
• Report Number: 3020347218-2023-00011
• Device Sequence Number: 5260423
• Product Code: QEW
• UDI-Device Identifier: 00850291007192
• UDI-Public: 00850291007192
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K211013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11-102
• 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: 05/31/2023
• Initial Report FDA Received Date: 06/30/2023
• 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: INARI TRIEVER20
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female
• Patient Weight: 68 KG