MAUDE Adverse Event Report: INARI MEDICAL, INC. 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	Abdominal Pain (1685); Cardiac Arrest (1762); Tachycardia (2095); Ventricular Fibrillation (2130); Low Oxygen Saturation (2477); Thromboembolism (2654); Respiratory Arrest (4461)
Date of Event	02/18/2022
Type of Reportable Event	Death
Event or Problem Description
A (b)(6)-year-old female patient presented to the emergency department on (b)(6) 2022 with left leg pain and swelling and was diagnosed with a deep vein thrombosis (dvt) in her left leg.Following an interventional radiology consultation, the patient was admitted to the hospital, and intravenous heparin was administered.Based on no changes in the patient's symptoms, dvt surgical intervention was scheduled for (b)(6) 2022.Preoperative ultrasound revealed significant left-sided iliofemoral dvt with short extension into the ostium of the inferior vena cava (ivc).The surgical plan was to obtain bilateral popliteal access and deploy inari flowtriever xl disks at the atrial-caval junction for embolic protection and engage left-sided thrombus with the inari clottriever (ct).After performing a left-sided venogram using a 5fr vert catheter, a right-sided venogram was performed with a second 5fr vert catheter which demonstrated a severely stenotic femoral vein with multiple mature collaterals and a native vessel looked like it may be too small to accommodate the 12fr catheter for the xl disk.Serial dilation was employed on the right side to upsize from a 6fr sheath to an 11fr sheath and flowtriever xl disk delivery was attempted, but the vessel diameter proved too small so disk deployment was abandoned.Due to the absence of a current pulmonary embolism (pe) diagnosis and the clot location immediately beyond the common iliac with minimal extension into the ostium of the ivc, the physician elected to proceed with the left-sided dvt thrombectomy without embolic protection.The ct sheath was inserted and the ct catheter was deployed.The ct catheter encountered stiff resistance in the external iliac so balloon dilation was performed from the external iliac to the common femoral / femoral.The ct catheter was advanced and the first pass yielded significant acute thrombus.However, after the second pass the patient complained of abdominal pain; at this time her oxygen (o2) saturation decreased from 99% (baseline, room air) to 84%, and her heart rate (hr) decreased from 113 (baseline) to 78 bpm.The procedure was paused to address the o2 saturation and assess patient status.During this pause o2 saturation briefly recovered and hr increased to the low 100's.While cleaning the ct catheter for the third pass, the patient's o2 saturation dropped into the 80% range and the patient was not responding well to verbal instruction.A non-rebreather mask was placed; however the patient became unresponsive.A code blue was initiated and the patient was moved from the operating table to a hospital gurney in the supine position to clear the airway.Radial pulses were absent and cpr was initiated.Intubation was performed and internal jugular access was gained for drug delivery.Intrinsic heart rate was restored briefly, but the heart rhythm devolved into ventricular fibrillation/pulseless ventricular tachycardia.Cpr was reinitiated, external defibrillation was performed, and tpa was administered.The code continued with patient requiring multiple defibrillation shocks, epinephrine dosing, and cpr to maintain perfusion.Despite several brief periods of return to intrinsic sinus rhythm, the patient was unable to maintain her heart rate or intrinsic respiration.After administering cpr for approximately 35 minutes, the decision was made to discontinue life-sustaining measures and the patient subsequently expired.
Additional Manufacturer Narrative
The inari devices were discarded by the user facility and are not available for evaluation.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.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 death was the result of distal embolization of the clot.The ct sheath and flowtriever catheter did not cause or contribute to the reported event.Distal embolization of blood clots and cardiovascular collapse are listed in the device labeling as potential complications / adverse events.Manufacturer reference #: (b)(4).

• Brand Name: 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: 13773324
• Report Number: 3011525976-2022-00002
• Device Sequence Number: 4993551
• Product Code: QEW
• UDI-Device Identifier: 00850291007093
• UDI-Public: 00850291007093
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/15/2022

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: 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: 02/18/2022
• Initial Report FDA Received Date: 03/15/2022
• 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: CLOTTRIEVER SHEATH 13 FR; FLOWTRIEVER CATHETER (25 MM) XL; VERT CATHETER 12 FR; VERT CATHETER 5 FR
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Death
• Patient Age: 67 YR
• Patient Sex: Female