MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER24; 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 Codes	Cardiac Arrest (1762); Cardiogenic Shock (2262); Embolism/Embolus (4438)
Date of Event	04/13/2023
Type of Reportable Event	Death
Event or Problem Description
A female in her early 60s presented to the emergency department with shortness of breath and the ct angiogram (cta) revealed a diagnosis of bilateral pulmonary embolism (pe).The patient did not improve with thrombolytic medical therapy (tpa) and underwent a thrombectomy with the inari flowtriever retrieval/aspiration system on (b)(6), 2023.Local anesthesia with sedation and heparin were administered.Access was obtained in the right common femoral vein using the inari intri24 sheath and the amplatz super stiff guidewire was used to obtain wire position.While aspirating, the clot became lodged in the tip of the triever24 (t24) catheter.Due to the large clot size, it would not aspirate through the t24 and was pulled into the inferior vena cava (ivc).The flowtriever xl disks were placed from the left groin, above the clot, and the flowtriever2 was used in conjunction with the t24 to remove a significant amount of clot.The clottriever catheter was then used to address the remaining clot.However, based on cta analysis, it appears there were multiple times in which the disks were not deployed during the clot retrieval process.Clot was then observed on the ivc angiogram to have traveled back to the heart.Unfortunately, the patient arrested and was unable to be resuscitated.Additional information has been requested.
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.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's chief medical officer, who concluded that the patient's death was the result of distal embolism.The inari intri24, flowtriever2, flowsaver, and clottriever catheter devices are not suspected as contributing to the event.Distal embolization, cardiac injury, cardiogenic shock, clinical deterioration, and death are listed in the device labeling as potential complications / adverse events.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 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: 16916730
• Report Number: 3020347218-2023-00007
• Device Sequence Number: 6910705
• Product Code: QEW
• UDI-Device Identifier: 00850291007185
• UDI-Public: 00850291007185
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2023

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?: 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: 04/13/2023
• Initial Report FDA Received Date: 05/11/2023
• 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: AMPLATZ SUPER STIFF 1 CM TIP; GORE DRYSEAL; INARI CLOTTRIEVER CATHETER; INARI FLOWSAVER; INARI FLOWTRIEVER2; INARI INTRI24
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Death
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 82 KG