MAUDE Adverse Event Report: INARI MEDICAL, INC. INARI TRIEVER24; EMBOLECTOMY CATHETER

Model Number	22-101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Respiratory Arrest (4461)
Date of Event	11/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A (b)(6)-year-old male patient with covid was in the intensive care unit and scheduled to undergo a thrombectomy.Computerized tomography angiography (cta) identified a preexisting massive saddle pulmonary embolism (pe) with bilateral clot burden in both lungs.On (b)(6) 2021 the inari triever 24 was used to treat the pe.The procedure was performed independently and the event described below was first reported to inari on (b)(6) 2021.General anesthesia was administered and the amplatz super stiff 1 cm guidewire was used to position the triever 24 (t24) in the right lung; several aspirations yielded significant clot.After the right side was confirmed to be clear of clot, the physician repositioned the t24 to the left lung.One aspiration was attempted on the left side, but due to the large amount of clot present, the entire clot was unable to be suctioned into the t24.This resulted in a portion of the clot suctioned inside the catheter and the remaining portion outside of the t24.In order to remove the clot, the physician walked the t24 back slowly using the (t24) large bore syringe to provide vacuum.When trying to pass the pulmonic valve, the t24 syringe immediately filled with blood, indicative of the external clot portion dislodging from the catheter.The patient started to hemodynamically worsen and cardiopulmonary resuscitation was performed for approximately 15 minutes before the patient stabilized.Cta revealed that the dislodged clot was now present on the right side and occluding the entire pulmonary artery.After a few aspirations with the t24, the clot was removed and the patient improved significantly.Post procedural monitoring revealed the patient's hemodynamics improved further.The patient's pre- and post-treatment pulmonary artery (pa) pressures are provided in b6.The estimated blood loss during the procedure was approximately 500 cc and approximately 80% of the clot was removed (heparin bolus administered).Patient follow-up information is being requested from the physician.
Additional Manufacturer Narrative
The inari device was discarded by the user facility and is 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 clinical deterioration was the result of an embolized clot.Distal embolization and clinical deterioration are listed in the device labeling as potential complications/adverse events.Manufacturer reference #: (b)(4).

• Brand Name: INARI TRIEVER24
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): INARI MEDICAL, INC.; 9 parker; suite 100; irvine CA 92618
• Manufacturer (Section G): INARI MEDICAL, INC.; 9 parker; suite 100; irvine CA 92618
• Manufacturer Contact: kit cariquitan ; 9 parker; suite 100; irvine, CA 92618 ; 9496008433
• MDR Report Key: 13057714
• Report Number: 3011525976-2021-00022
• Device Sequence Number: 19234582
• Product Code: QEW
• UDI-Device Identifier: 00850291007185
• UDI-Public: 00850291007185
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K211013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/21/2021

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: 03/11/2023
• Device Model Number: 22-101
• Device Lot Number: 21030020
• 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: 12/08/2021
• Initial Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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 SUPER STIFF GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 56 YR
• Patient Sex: Male