MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER16 CURVE; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	25-201
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiogenic Shock (2262); Cardiac Perforation (2513)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
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 lot history records of all potential lots shipped to the facility were reviewed and 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 event was the result of inadvertent catheter perforation.Cardiac perforation, cardiac tamponade, and cardiogenic shock are identified in the labeling as possible adverse events/complications.Manufacturer reference #: (b)(4).
Event or Problem Description
A female patient with a bilateral pulmonary embolism (pe) presented to the emergency department and was scheduled for a thrombectomy with the inari flowtriever system on (b)(6) 2024.The clot age was estimated at 8 days.The initial thrombectomy was successful in removing approximately 80% of the clot burden, but the physician wanted to retrieve a small clot remaining in the truncus anterior.The physician attempted to pass the triever16 curve over a wholey guidewire to the right truncus anterior.However, the right ventricle perforated and the patient arrested; a code was initiated.The patient was unresponsive for 30 minutes, however, intervention measures (extracorporeal membrane oxygenation (ecmo) and intubation) were ultimately successful in achieving return of spontaneous circulation (rosc) and the patient's vitals were stable.Pericardiocentesis was performed with a large volume (300 cc) of blood removed and returned via the inari flowsaver and the inari intri24 sheath.The patient was transferred to the icu in stable condition and will be evaluated for any further intervention.

• Brand Name: TRIEVER16 CURVE
• 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: keith hebert ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 6513233614
• MDR Report Key: 18834250
• Report Number: 3020347218-2024-00013
• Device Sequence Number: 7181396
• Product Code: QEW
• UDI-Device Identifier: 00850291007437
• UDI-Public: 00850291007437
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K223419
• 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): 03/04/2024

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: 25-201
• 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: 02/05/2024
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: FLOWSAVER.; INTRI24 SHEATH.; TRIEVER20 CURVE.; TRIEVER24.; WHOLEY GUIDEWIRE.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Female