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	Pulmonary Embolism (1498); Cardiac Arrest (1762); Dyspnea (1816); Vomiting (2144); Loss of consciousness (2418); Low Oxygen Saturation (2477); Cardiovascular Dysfunction/Insufficiency (4445)
Date of Event	01/26/2023
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 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 the result of distal embolization.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 55-year-old female presented to the emergency department and was diagnosed with left leg iliofemoral deep vein thrombosis (dvt).The patient was scheduled for a thrombectomy with the inari clottriever (ct) thrombectomy system on (b)(6) 2023; at the time of surgery, the clot age was estimated at 5 days.The ct sheath was placed in the patient and the ct catheter was advanced.The coring element was placed at the top of the iliacs starting in the intra vena cava (ivc).The physician initiated the first pass and the ct catheter moved 2 cm before feeling resistance.The ct catheter was re-sheathed inside of the patient and removed.Following the removal, the physician ballooned the illiacs at 3 locations with a 13 mm x 40 mm balloon.The ct catheter was inserted again, and 3 passes were performed, but this effort yielded no clot.A pigtail catheter was then inserted and a digital subtraction angiography was performed which revealed there was no clot present.At this point, the patient reported difficulty breathing and her oxygenation (spo2) decreased from 100% to 84%.The physician attempted to stent the iliacs when the patient vomited and lost consciousness.A code was initiated, and the patient was repositioned to supine to enable chest compressions which continued for over 20 minutes during which time a pulse returned intermittently.Once the patient's circulation was stable, the patient was transferred to the intensive care unit.Unfortunately, the patient later died sometime between (b)(6) 2023 and (b)(6) 2023.

• 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: 16421595
• Report Number: 3020347218-2023-00002
• Device Sequence Number: 15049143
• Product Code: QEW
• UDI-Device Identifier: 00850291007093
• UDI-Public: 00850291007093
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K221531
• 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): 02/22/2023

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: 12/06/2023
• Device Model Number: 40-102
• Device Lot Number: 21120005
• 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: 01/26/2023
• Initial Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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: 14 MM X 40 MM BALLOON.; INARI CLOTTREIVER SHEATH 13 FR.; PIGTAIL CATHETER.
• Outcome Attributed to Adverse Event: Hospitalization; Death; Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 98 KG