MAUDE Adverse Event Report: INARI MEDICAL, INC. INARI CLOTTRIEVER CATHETER; EMBOLECTOMY CATHETER

Model Number	40-102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418); Low Oxygen Saturation (2477); Intraoperative Pain (2662); Embolism/Embolus (4438); Respiratory Arrest (4461)
Date of Event	10/19/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The inari device 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.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 event was reviewed by inari's chief medical officer, who concluded that the patient's deterioration and death may have been due to potential clot embolization that resulted in a pulmonary embolism and death.Distal embolization of blood clots and patient deterioration are listed in the device labeling as potential complications / adverse events.Manufacturer reference #: (b)(4).
Event or Problem Description
A (b)(6) male who had undergone a knee replacement and lumbar surgery years ago presented with right sided deep vein thrombosis (dvt).The pulmonary embolism (pe) scan was negative and the inferior vena cava was presumed clear per the physician.On (b)(6) 2021, the inari clottriever (ct) thrombectomy system (ct catheter and ct sheath) was used to attempt to treat the dvt.After dilation, a 16 fr clottriever (ct) sheath was used and the patient was placed in the prone position.The patient's baseline vital signs were as follows: blood pressure (bp) 123/83 mmhg, oxygen saturation (spo2) 100% on room air, heart rate (hr) high 80's (bpm).The first pass was performed with the ct catheter and yielded significant clot, during which time the patient reported experiencing mild pain.The ct was cleaned, re-sheathed, and introduced for a second pass.As the ct was pulled through the right innominate vein (riv) the patient reported severe pain and nausea and vomited.Zofran was administered intravenously and the patient lost consciousness.All vital signs remained stable and the second pass also yielded significant clot.A third pass also yielded (lesser) clot.Bleed back was observed at the sheath and patient's spo2 decreased to 92% and bp decreased to 109/75.A nasal cannula was placed on the patient which increased oxygenation to 97%.At this point approximately 80% of the clot burden had been removed and a venogram revealed two clots remaining near the bifurcation.During discussion on how to retrieve the remaining clot s and over the course of approximately 8 minutes, the patient's spo2 and bp decreased further, then spo2 drastically deteriorated to 70% (on a non-rebreather mask) and bp decreased to 74/48.A code was initiated and the patient was repositioned supine onto the bed and cpr was administered.The code team attempted resuscitation efforts for approximately 25 minutes before the patient expired.The cause of death remains unknown and there was no additional information available to understand whether the patient had unknown underlying conditions that would explain the event.

• Brand Name: INARI CLOTTRIEVER CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• 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: 12837311
• Report Number: 3011525976-2021-00019
• Device Sequence Number: 11870880
• Product Code: QEW
• UDI-Device Identifier: 00850291007093
• UDI-Public: 00850291007093
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210689
• 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): 11/18/2021

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: 40-102
• 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: 10/19/2021
• Initial Report FDA Received Date: 11/18/2021
• 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 CLOTTRIEVER SHEATH 16 FR
• Outcome Attributed to Adverse Event: Death; Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male