MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER20 CATHETER; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	21-101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Vertigo (2134); Visual Disturbances (2140); Anxiety (2328)
Date of Event	03/28/2024
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.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 stroke was the result of the thrombectomy procedure.The patient also had a patent foramen ovale, which is a possible contributing factor.Distal embolism, stroke, and clinical deterioration, are listed in the device labeling as potential complications / adverse events.Manufacturer reference #: (b)(4).
Event or Problem Description
A 71-year-old female patient with esophageal cancer was diagnosed with bilateral pulmonary embolism (pe) via computed tomography angiography.The patient was scheduled for thrombectomy using inari devices.The clot age was estimated at 7 days.Wire positioning was obtained without issue and a triever20 (t20) catheter was advanced into place.An aspiration was performed in the right pulmonary artery which did not yield clot.The t20 was advanced again, and a second aspiration was performed; however, the clot became lodged in the tip of the t20.The physician proceeded to remove the t20 catheter from the patient through the inari intri24 sheath.Upon initial examination, there was no clot present in the large bore syringe or catheter.The intri24 sheath was removed under pressure and flushed, which yielded a large portion of clot.There was also a large clot present at the access site which was removed manually.The intri24 sheath and t20 catheter were cleaned and advanced back into place when the patient reported experiencing diplopia in the left eye and vertigo and showed signs of restlessness.A rapid response was initiated; the patient responded to verbal commands, but was unable to verbalize or open her eyes.It was determined that the patient was experiencing a stroke.It is assumed that the procedure was concluded, and the patient was sent for stroke treatment and admitted to the intensive care unit.Patient follow-up revealed that the patient had an undiagnosed patent foramen ovale (pfo).The patient was observed with a left middle cerebral artery occlusion as well as thrombus within the right common carotid.

• Brand Name: TRIEVER20 CATHETER
• 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: 19169748
• Report Number: 3020347218-2024-00020
• Device Sequence Number: 7856218
• Product Code: QEW
• UDI-Device Identifier: 00850291007079
• UDI-Public: 00850291007079
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/23/2024

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: 21-101
• 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: 03/28/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 125 CM VERT CATHETER; ANGLED PIGTAIL CATHETER; BENSON WIRE; INTRI24 SHEATH
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Disability; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female