MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER24; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	22-101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Cardiovascular Dysfunction/Insufficiency (4445)
Date of Event	06/11/2024
Type of Reportable Event	Death
Event or Problem Description
A 64-year-old male presented to the emergency room with shortness of breath and an episode of presyncope.Imaging was performed which revealed a pulmonary embolism, positive biomarkers, and evidence of right heart strain.After a consultation, it was determined that the patient would undergo a thrombectomy with the inari flowtriever system.The procedure began without issue and wire positioning was obtained.An activated clotting time (act) test was performed which resulted in a value of 127.This led to an adjustment and increase in anticoagulation to reach the goal of act 250-300.The triever24 (t24) was advanced into the mid basal branch and an aspiration was performed.This resulted in cavitation and an additional vacuum was applied.While maintaining wire positioning, the t24 was walked back and slowly filled.No thrombus was seen.The flowsaver was used, and a second attempt was made to aspirate.This also resulted in cavitation.Contrast was injected to visualize the thrombus.A large thrombus was observed on the tip of the t24 outside of the sheath.The decision was made to use flowtriever xl discs to prevent re-embolism but before they would be inserted, the physician removed the t24 and lost the thrombus.The patient became restless and tachycardic.More aspirations were attempted but the results were the same as the first 2 attempts.No thrombus was removed, and the patient became progressively worse.The rapid response team was called and worked on the patient for 15 minutes.Eventually, a full code was called but despite resuscitation efforts, the patient unfortunately expired.
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 death was likely the result of distal clot embolism.Distal embolization of blood clots and cardiovascular collapse are identified in the device labeling as possible adverse events/complications.

• Brand Name: TRIEVER24
• 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: 19715427
• Report Number: 3020347218-2024-00030
• Device Sequence Number: 8513809
• Product Code: QEW
• UDI-Device Identifier: 00850291007185
• UDI-Public: 00850291007185
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K213402
• 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): 07/10/2024

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: 22-101
• 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: Not provided
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Death
• Patient Age: 64 YR
• Patient Sex: Male