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

Model Number	42-102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Bradycardia (1751); Cardiac Arrest (1762); Hypoxia (1918); Loss of consciousness (2418); Intraoperative Pain (2662); Renal Impairment (4499)
Date of Event	05/16/2023
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 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 case was reviewed by inari's chief medical officer, who concluded that the patient's deterioration was the result of clot embolism and/or sedation.Distal embolization of blood clots and cardiovascular collapse are listed in the device labeling as potential complications / adverse events.Manufacturer reference#: (b)(4).
Event or Problem Description
A 71-year-old female with left leg deep vein thrombosis (dvt) underwent a thrombectomy with the inari clottriever thrombectomy system after experiencing symptoms for 2 days.The patient's high creatinine level limited the extent of fluoroscopic imaging; although visualization of the inferior vena cava (ivc) was sub-optimal, the physician deemed it sufficient to initiate the procedure.The patient was placed in the prone position and the left popliteal vein was cannulated.A glidewire advantage was used to navigate the ivc; the wire met resistance at the confluence and then crossed into the contralateral side (rt) common iliac.A clottriever sheath 13 fr was inserted and the clottriever bold catheter was advanced.After the first pass, the patient reported experiencing pain and the heart rate and oxygen saturation (spo2) decreased.Additional sedation was administered and a second pass was performed which resulted in a subsequent decrease in heart rate (hr) and spo2.The patient became unresponsive with spo2 fluctuation, but no change in hr.The procedure was stopped, and the patient was moved to a bed for observation.During observation, the patient decompensated and a code was initiated.Cardiopulmonary resuscitation (cpr) was administered, the patient was intubated, and vasopressor medication was given.Blood gases were drawn revealing the patient was acidotic and required dialysis.A pulmonary embolism (pe) was suspected so a thrombectomy with the inari flowtriever system was performed.A bilateral pe was confirmed and the procedure was successful with clot removed.When the patient was being taken to her recovery room, her central venous pressure (cvp) improved from 30 mmhg (high) to 10-11 mmhg (normal range) and her heart rate was stable in the 80 bpm range.Patient follow-up information has been requested.

• Brand Name: CLOTTRIEVER BOLD 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: kit cariquitan ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 8779234747
• MDR Report Key: 17139927
• Report Number: 3020347218-2023-00008
• Device Sequence Number: 20338797
• Product Code: QEW
• UDI-Device Identifier: 00850291007314
• UDI-Public: 00850291007314
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K230494
• 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): 06/15/2023

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 Expiration Date: 12/05/2024
• Device Model Number: 42-102
• Device Lot Number: 22110146
• 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: 05/16/2023
• Initial Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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: GLIDEWIRE ADVANTAGE; INARI CLOTTRIEVER SHEATH 13 FR
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 104 KG