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	Cardiac Arrest (1762); Cardiac Tamponade (2226); Cardiac Perforation (2513)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A 58-year-old female patient with a complex medical history (described in b7) had been experiencing shortness of breath for 2 weeks.A computerized tomography (ct) scan revealed pulmonary embolism (pe) and the clot age was estimated at 2 weeks.A thrombectomy was performed with the inari flowtriever system to address the pe.After wire positioning was obtained, two aspirations were performed with the triever24 (t24) catheter which yielded very chronic and substantial clot.The physician then attempted to re-wire to the left side with the amplatz guidewire, but needed to use a j wire and penumbra 5f 130 catheter.When the t24 was unable to advance past the main pulmonary artery, the triever16 (t16) curve was used through the t24.The t16 was pointed down at the super segment branch level and there was no wire visualization through the t16 catheter.The guidewire was pulled back and the amplatz guidewire was advanced.However, the t16 curve was curved in an unexpected manner and the physician suspected that the t16 may have been positioned in the heart.The t24 and t16 catheters were pulled back (together) into the main pulmonary artery.Imaging was performed in which contrast did not fill the lungs indicating a perforation.The patient subsequently arrested, and a code was initiated and all devices were removed from the patient.Chest compressions were administered and a pulse was regained.The patient was intubated and a pericardiocentesis was performed to address pericardial tamponade.The patient was transferred to the icu where they were weaned off vasopressors 3 days later.At last report the patient was sedated and intubated with stable vital signs.
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 deterioration was the result of inadvertent cardiac perforation.Cardiac perforation, cardiac tamponade, vessel dissection/perforation, cardiac injury, cardiogenic shock, and clinical deterioration are listed in the device labeling as potential complications / adverse events.This report is being filed for the t24 device.Refer to mfr report # 3020347218-2023-00015 for the report on the t16 curve device.Manufacturer reference #: (b)(4).

• 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: kit cariquitan ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 8779234747
• MDR Report Key: 17408429
• Report Number: 3020347218-2023-00014
• Device Sequence Number: 12602044
• Product Code: QEW
• UDI-Device Identifier: 00850291007185
• UDI-Public: 00850291007185
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2023

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 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: 06/30/2023
• Initial Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 GUIDEWIRE; INTRI24 INTRODUCER SHEATH; J WIRE; PENUMBRA 5 FR 130 CATHETER; TRIEVER16 CURVE
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female