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); Cardiac Arrest (1762); Tachycardia (2095); Anxiety (2328); Low Oxygen Saturation (2477)
Date of Event	06/07/2023
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, the lot history records of all potential lots shipped to the facility 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.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 66-year-old male patient was diagnosed with left lower extremity ilio-femoral deep vein thrombosis (dvt).The clot age was estimated at 3 days.On (b)(6) 2023, a thrombectomy was planned with the inari clottriever (ct) bold catheter with left popliteal access.A venogram was performed which revealed extensive clot burden from the popliteal vein to the iliac vein.No clot was identified in the inferior vena cava (ivc).The surgical plan was to perform the thrombectomy without distal protection due to the clot location.Wire positioning was obtained with an amplatz guidewire, and the ct bold catheter was advanced.Three passes were performed which successfully retrieved a large clot burden.A venogram was taken after the third pass which revealed a large thrombus in the iliac/ivc had floated up from what was presumed to be the profunda artery.The physician repositioned to address this clot.A fourth pass was made, but it did not collect a sufficient amount of clot.At this point, the patient became restless, tachycardic, and hypoxic.A pulmonary embolism (pe) was suspected and the patient was repositioned from the prone position to supine in order to access the right common femoral vein.An echocardiogram revealed a dilated right ventricle with right ventricle failure and confirmed the presence of a pe.The patient continued to rapidly decline as the flowtriever catheter was being advanced to the pulmonary arteries.The patient arrested, a code was initiated, and cardiopulmonary resuscitation (cpr) was administered.A successful pe thrombectomy was performed and tpa was administered.Cpr was performed for a total of 36 minutes and the patient was placed on extracorporeal membrane oxygenation (ecmo).After the pe thrombectomy, an echocardiogram showed a normal right ventricle.The patient was transferred to the intensive care unit (icu).The patient remained in the icu on ecmo support for 5 days, but did not recover neurologically.The decision was eventually made to withdraw life support and the patient died on (b)(6) 2023.

• 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: 17269174
• Report Number: 3020347218-2023-00012
• Device Sequence Number: 7966929
• 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): 07/06/2023

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 Model Number: 42-102
• 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: 06/07/2023
• Initial Report FDA Received Date: 07/06/2023
• 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; CLOTTRIEVER SHEATH, 13 FR
• Outcome Attributed to Adverse Event: Death; Required Intervention; Life Threatening; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male