MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER24; THROMBECTOMY SYSTEM

Model Number	22-101
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	06/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A 68-year-old male patient with a pulmonary embolism underwent attempted embolectomy with the inari flowtriever on (b)(6) 2022.Four weeks prior to the procedure, a ct angiogram revealed a mass adhering to the wall in the main right pulmonary artery (rpa) towards the tricuspid artesia (ta) and upper lobe.During the procedure, 3 biopsy tissue samples were taken to determine the nature of the mass since the patient had an extensive history of renal cancer.The patient was placed under local anesthesia with sedation and good, stable guidewire position was achieved in the ta.Due to intrajugular access, the curve in the wire was a bit steep towards the pulmonary arteries.The patient's right ventricle was not under strain and therefore small, which made the curve even steeper.Proper dilation of the access site was performed, and the gore dry sheath (gds) was placed successfully.The triever24 (t24) was then introduced and advanced.There was difficulty advancing the t24 at the steep curve and a decision was made to exchange the t24 with the triever16.When the triever16 was being handed to the physician (prior to use), the patient complained of pain in the stomach area and collapsed.A pericardial drainage was prepared and performed in 3 different drains; 2 liters of blood were aspirated and returned to the patient via a sideport.Urgent open-heart surgery was performed, and the perforation was sutured.Due to the rapid response and absence of cardiac arrest, the patient is expected to make a full recovery without any brain damage.The surgeon elected not to proceed with the embolectomy procedure and the access site was closed.At last report, the patient was in stable condition and additional information has been requested.
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 vascular injury was the result of perforation, potentially exacerbated by abnormal patient anatomy; in addition, the treating physician thought the patient's carcinoma history may have made the ventricle more susceptible to perforation.Cardiac perforation, valvular disruption/injury, pericardial effusion, pain, and clinical deterioration are listed in the device labeling as potential complications/adverse events.Manufacturer reference #:(b)(4).

• Brand Name: TRIEVER24
• Common Device Name: THROMBECTOMY SYSTEM
• 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: 14721950
• Report Number: 3011525976-2022-00008
• Device Sequence Number: 11989241
• Product Code: QEW
• UDI-Device Identifier: 00850291007185
• UDI-Public: 00850291007185
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2022

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: 12/10/2023
• Device Model Number: 22-101
• Device Lot Number: 21120027
• 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: 06/03/2022
• Initial Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2022
• 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 1 CM; FLOWSAVER; GORE DRYSEAL SHEATH 26 FR
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male