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

Model Number	40-102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Embolism/Embolus (4438)
Date of Event	10/20/2022
Type of Reportable Event	Death
Event or Problem Description
A 27-year-old obese female patient presented with minimal swelling of the left leg.The patient was diagnosed with a deep vein thrombosis (dvt) in her left leg, and it was revealed she had a prior dvt in the same leg.A thrombectomy was scheduled for (b)(6) 2022 using the inari clottriever (ct) thrombectomy system.General anesthesia and a bolus of heparin were administered and access was gained.The popliteal vein was imaged, and wire position was obtained with the supra core 300 cm guidewire.The clottriever (ct) sheath 13 fr was prepared and the access site was dilated with a 13 fr dilator.The ct sheath was inserted and the funnel deployed successfully.A catheter was then inserted to image the subclavian and iliac.The clottriever catheter was inserted over the guidewire and the coring element was deployed in the lower inferior vena cava.During the first pass, the physician encountered "moderate resistance".While cleaning clot from the coring element, the patient's systolic blood pressure (bp) decreased to the 50 range and a faint pulse was detected.Within 2 minutes, the patient was repositioned, chest compressions were initiated, and 50 mg of tpa was administered.Resuscitation efforts continued, but the code team was unable to resuscitate the patient and she expired.
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 death was likely the result of pulmonary embolism caused by distal embolization.The instructions for use includes the following warning statement: avoid using excessive force to advance or retract the clottriever sheath and dilator against resistance.If excessive resistance is encountered, remove the device.Excessive force against resistance may result in damage to the clottriever sheath and dilator and/or vessel.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: 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: 15811743
• Report Number: 3020347218-2022-00006
• Device Sequence Number: 12199375
• Product Code: QEW
• UDI-Device Identifier: 00850291007093
• UDI-Public: 00850291007093
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K212632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2022

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 Expiration Date: 04/11/2024
• Device Model Number: 40-102
• Device Lot Number: 22040027
• 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: 10/20/2022
• Initial Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• 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.; SUPRA CORE 300 CM.
• Outcome Attributed to Adverse Event: Life Threatening; Death; Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic