MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER24; THROMBECTOMY SYSTEM

Model Number	22-101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Low Oxygen Saturation (2477)
Date of Event	04/01/2022
Type of Reportable Event	Death
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 company recorded all lots shipped to the facility and each of the possible lot history records were reviewed.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 distal embolization, potentially exacerbated by a suspected patent foramen ovale and that use of the inari device may have caused or contributed to the patient's stroke.Hypoxemia, distal embolism, stroke, clinical deterioration, and death are listed in the device labeling as potential complications / adverse events.Manufacturer reference #: (b)(4).
Event or Problem Description
A female patient in her early 70s presented with difficulty breathing and the computerized tomography (ct) angiogram revealed bilateral pulmonary embolism (pe) and deep vein thrombosis (dvt) in the left leg.On (b)(6) 2022, the inari triever24 (t24) was used to attempt to remove the pe.The patient was given local anesthesia with sedation and systemic heparin.Seven (7) passes were made with the t24, yielding approximately 70% of the clot burden; however, catheter cavitation with the t24 occurred twice during aspiration attempts.During the procedure the patient experienced a paradoxical stroke in the main coronary artery; a patent foramen ovale (pfo) was suspected.The patient was given comfort care and died around 3:00 am on (b)(6) 2022.Additional information was requested from the initial reporter on several occasions, but no response has been received to date.

• Brand Name: TRIEVER24
• Common Device Name: THROMBECTOMY SYSTEM
• Manufacturer (Section D): INARI MEDICAL, INC.; 9 parker; suite 100; irvine CA 92618
• Manufacturer (Section G): INARI MEDICAL, INC.; 9 parker; suite 100; irvine CA 92618
• Manufacturer Contact: kit cariquitan ; 9 parker; suite 100; irvine, CA 92618 ; 9496008433
• MDR Report Key: 14570532
• Report Number: 3011525976-2022-00007
• Device Sequence Number: 4904860
• Product Code: QEW
• UDI-Device Identifier: 00850291007185
• UDI-Public: 00850291007185
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2022

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: 05/03/2022
• Initial Report FDA Received Date: 06/01/2022
• 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 GUIDEWIRE; FLOWSAVER; GORE DRYSEAL SHEATH 26 FR; SWAN CATHETER
• Outcome Attributed to Adverse Event: Life Threatening; Death; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female