MAUDE Adverse Event Report: INARI MEDICAL, INC. INARI TRIEVER16; EMBOLECTOMY CATHETER

Model Number	25-101
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Hypovolemic Shock (1917); Hypoxia (1918); Oversedation (1990); Loss of consciousness (2418); Respiratory Arrest (4461)
Date of Event	12/23/2020
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.Clinical deterioration, pain, and death are listed in the device labeling as a potential complications / adverse events.This mdr is for the inari triever16 device.Refer to mdr #3011525976-2021-00004 for the other inari device involved in this event.(b)(4).
Event or Problem Description
A (b)(6)-year-old female patient with chronic obstructive pulmonary disease presented to the emergency department with chest pain on (b)(6) 2020.She was admitted to the catheterization lab, where she underwent percutaneous coronary intervention and received 2 coronary stents.On (b)(6) 2020, as the patient was recovering from the procedure, she began experiencing chest pain with shortness of breath.A ct angiogram revealed a saddle pulmonary embolism (pe) with bilateral clot burden.On (b)(6) 2020, the inari medical triever20 (t20), triever16 (t16), and medium flowtriever (ft) disks were used to attempt to treat the pe.Prior to the case, it was noted that the patient had some right ventricle strain, elevated troponin levels, and a hemoglobin level of over 12 g/dl.As the case began, the patient's heart rate was between 130-150 bpm, and blood pressure was 152/72 mmhg.Access was gained via the right common femoral vein, and a bentson wire and angled pigtail catheter were used to successfully cross the heart and advance to the main pulmonary artery (pa); the pa pressure was 54/30/14 mmhg.The wire was then maneuvered to the right pa and exchanged for a boston scientific amplatz super stiff guidewire (1 cm) which was anchored in a medial position in the basal trunk.A gore dryseal sheath was placed, then the t20 was inserted and advanced to the saddle clot.One aspiration was performed, yielding no clot.The medium ft disks were deployed, and another aspiration was performed, yielding no clot.The physician advanced the t20 into the clot before performing a third aspiration that did not retrieve any clot.The t16 was then inserted through the t20 and advanced deeper, yielding a small amount of chronic clot.During the right pa aspirations, the patient verbalized discomfort and sedation was increased.The inari devices were moved to the truncus anterior, and after deploying the medium ft disks, 2 aspirations yielded chronic clot.The left pa was accessed, where 4-5 aspirations were performed using a combination of the t20, t16, and medium ft disks, collectively yielding a moderate amount of clot.At 90 minutes into the case, there was an estimated blood loss of 660 ml, and the physician navigated a pigtail catheter to the main pa, ready to take a final pressure measurement before concluding the procedure.No significant hemodynamic issues were noted.Shortly after the thrombectomy was completed the patient began to decompensate, becoming unresponsive.A code was initiated, and chest compressions were initiated.The physician ordered that the sedation be discontinued, and after 2-3 minutes, resuscitation efforts were successful, and the patient responded to commands.Ten minutes later, the patient arrested again and was successfully resuscitated and transferred to the intensive care unit.It was later learned that the patient decompensated twice (approx.Approximately 60-90 minutes after being transferred to the icu) before expiring.It should be noted that the patient's family had made the decision to sign a do not resuscitate (dnr) order.The physician attributed the patient's deterioration to a combination of her underlying disease, blood loss, and sedation.

• Brand Name: INARI TRIEVER16
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): INARI MEDICAL, INC.; 9 parker; suite 100; irvine CA 92618
• MDR Report Key: 11211512
• Report Number: 3011525976-2021-00005
• Device Sequence Number: 3285999
• Product Code: QEW
• UDI-Device Identifier: 00850291007130
• UDI-Public: 00850291007130
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K183198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2021

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: 25-101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZ SUPER STIFF GUIDEWIRE.; GORE DRYSEAL FLEX INTRODUCER SHEATH.; INARI FLOWTRIEVER CATHETER (M).; INARI TRIEVER20.
• Outcome Attributed to Adverse Event: Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 73