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); Cardiac Arrest (1762); Low Oxygen Saturation (2477)
Date of Event	11/21/2023
Type of Reportable Event	Death
Event or Problem Description
An 86-year-old male patient underwent a thrombectomy procedure to address thrombus that was adherent to a pacemaker lead.Prior to access, a transesophageal echocardiogram (tee) was used to visualize the mass.The procedure began without issue and wire positioning was successfully obtained.The inari triever24 (t24) was advanced into place and a total of 5 aspirations were performed which yielded no clot.The physician elected to re-wire into the pulmonary arteries and the t24 was re-introduced.An aspiration was performed, but no clot was retrieved.A second aspiration was performed which yielded the same result.At this point, the tee revealed that the mass appeared different than in prior images indicating a pulmonary embolism.The patient's oxygenation saturation decreased rapidly (50-60% range), and the patient's cardiac activity declined.A code was initiated and cardiopulmonary resuscitation was administered along with additional life-saving measures.The patient was intubated, and imaging was attempted to identify the location of the mass.Unfortunately, the physician was unable to obtain access due to difficulty crossing the heart.Eventually a miv catheter was placed in the right interlobar artery, and a digital subtraction angiography run was performed.No clot was observed.Unfortunately, the patient expired despite resuscitation efforts.
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 death was the result of clot embolism.Distal embolism and death are identified in the device labeling as potential complications/adverse events.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: keith hebert ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 6513233614
• MDR Report Key: 18332419
• Report Number: 3020347218-2023-00027
• Device Sequence Number: 8425429
• Product Code: QEW
• UDI-Device Identifier: 00850291007185
• UDI-Public: 00850291007185
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 12/14/2023

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: 11/21/2023
• Initial Report FDA Received Date: 12/14/2023
• 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 7 CM AND 1 CM.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Death
• Patient Age: 86 YR
• Patient Sex: Male