MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER20 CURVE; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	21-201
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	08/14/2024
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, 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 injury and deterioration was the result of catheter perforation.Manufacturer reference #: (b)(4).Cardiovascular collapse, pericardial effusion, and vessel dissection/perforation are identified in the device labeling as possible adverse events/complications.
Event or Problem Description
An 81-year-old female underwent a thrombectomy with the inari flowtriever system to address her pulmonary embolism.A stiff angled glidewire was used in conjunction with a vert catheter to wire the truncus anterior.The wire appeared to advance in the appropriate direction within the vessel.The glidewire was exchanged for an amplatz superstiff guidewire.The triever20 curve was introduced coaxial with the triever24 to the right pulmonary artery (rpa) and an aspiration was performed.The physician performed a selective angiogram of the rpa when it was noticed that the image looked odd.The catheters were pulled back, and another angiogram was performed which revealed extravasation of contrast and a large pericardial effusion.The procedure was halted, and the patient decompensated.An echocardiogram was performed which confirmed the pericardial effusion.A pericardial drain was inserted but the patient continued to decompensate.The patient was intubated, and a transesophageal echocardiogram probe was placed.Multiple attempts were made to allow the bleeding to stop on its own.At one point the surgical team prepped the patient and the patient's chest was opened for repair.The patient survived the surgery during which a laceration in the anterior right ventricle outflow tract was discovered.

• Brand Name: TRIEVER20 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: 20207802
• Report Number: 3020347218-2024-00041
• Device Sequence Number: 20537073
• Product Code: QEW
• UDI-Device Identifier: 00850291007215
• UDI-Public: 00850291007215
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K231848
• 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): 09/12/2024

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: 21-201
• 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: 08/14/2024
• Initial Report FDA Received Date: 09/12/2024
• 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: AMPLATZ SUPERSTIFF GUIDEWIRE; FLOWSAVER; INTRI24 SHEATH; STIFF ANGLED GLIDEWIRE; TRIEVER24; VERT CATHETER
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female