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

Model Number	21-201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Chest Pain (1776); Hemoptysis (1887); Ventricular Fibrillation (2130); Cardiac Perforation (2513); Intraoperative Pain (2662)
Date of Event	11/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
An 88-year-old female patient presented to the hospital with mild right heart strain.Computed tomographic angiography (cta) confirmed the presence of clot in the right interlobar and truncus as well as small clot on the left interlobar.The patient was diagnosed with pulmonary embolism (pe).Additionally, the patient had a "do not resuscitate" (dnr) order and had been in a motor vehicle accident one month prior where she sustained hip fractures.The clot age was estimated at 10 days.A thrombectomy was performed with the inari flowtriever system.Wire positioning was obtained and the triever24 (t24) was advanced.A single aspiration was performed which yielded clot.The physician then repositioned into the truncus in which another aspiration was performed.The physician then pulled the t24 into the main pulmonary artery when it was noted that the guidewire appeared to be in the left interlobar area and advanced slightly.The wire was not distal but was facing inferior.The physician opened a triever20 curve (t20c) catheter and advanced it over the guidewire.While advancing the t20c catheter, the patient complained of chest pain despite exhibiting stable vital signs.The physician performed imaging with contrast which showed an image filled with contrast.The patient complained of chest pain again and began showing signs of hemoptysis.The patient was rotated to address the hemoptysis and a second angiogram was performed which revealed an extravasation.The patient deteriorated rapidly and a code was initiated.The patient entered ventricular fibrillation and a defibrillator was used and cardiopulmonary resuscitation was administered.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.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 inadvertent catheter perforation.Cardiac perforation and death are listed in the device labeling as known potential complications/adverse events.Manufacturer reference #: (b)(4).

• 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: 18263822
• Report Number: 3020347218-2023-00025
• Device Sequence Number: 3905353
• Product Code: QEW
• UDI-Device Identifier: 00850291007215
• UDI-Public: 00850291007215
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2023

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: 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: 11/04/2023
• Initial Report FDA Received Date: 12/04/2023
• 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 SUPER STIFF GUIDEWIRE; AP2 CATHETER; BENTSON WIRE; GORE DRY-SEAL SHEATH; TRIEVER24
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Death
• Patient Age: 88 YR
• Patient Sex: Female