MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER20 CATHETER; EMBOLECTOMY CATHETER

Model Number	21-101
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded by the user facility and is not available for evaluation.The device identifier was not provided, however the company recorded all lots shipped to the facility and each of the possible lot history records were reviewed.There were no discrepancies or unusual findings that relate to the reported event.The case was reviewed by inari's chief medical officer, who concluded that the pulmonary dissection was caused by advancement of the triever20 catheter without the dilator.Vessel dissection is listed in the device labeling as a potential complication / adverse event.Manufacturer reference #: (b)(4).
Event or Problem Description
A (b)(6)-year-old male patient with a history lung cancer with prior chest irradiation presented to the hospital in early (b)(6) 2020 with symptoms of a pulmonary embolism (pe).Heparin was administered, but the patient was ineligible for thrombolytic therapy (bleeding risk).Computed tomography angiography (cta) revealed the patient had bilateral pe.The baseline vital signs were: heart rate 95 bpm, blood pressure 120/73, and o2 saturation 95% on a non-rebreather mask at 6l o2.On (b)(6) 2020, the inari triever20 (t20) was used to attempt to treat the bilateral pe.Ultrasound was used to guide access to the right common femoral vein.An 8 fr sheath was inserted over the guidewire, followed by an angled pig tail catheter which was used to cross the right heart to obtain pulmonary artery pressure (36/18).The pig tail catheter was then exchanged for a boston scientific amplatz super stiff guidewire (260 cm), which was advanced to the lateral branch of the left lower lobe.The access site was then dilated to accommodate a 22 fr gore dryseal sheath.Following insertion of the gore sheath, the t20 was successfully inserted and advanced to the left pulmonary artery.A total of 4 aspirations were performed with the t20; two of these aspirations successfully retrieved minimal and moderate amounts of clot.The inari triever16 (t16) was then used to address clot residing in the distal vasculature.The t16 was inserted through the t20 and advanced into the interlobar segment.Aspiration was first performed using the t16, which was then walked back to the t20, which was used to aspirate as well.The t16 was removed and flushed, yielding a small clot.This technique was performed again, yielding a small clot.The surgeon then focused on the right pulmonary artery (rpa).With the t16 removed from the patient, the t20 was drawn back into the main pulmonary artery (mpa), and a 125 cm vert catheter was inserted through the t20 to assist with wire manipulation.The guidewire and vert catheter were then both successfully advanced to the rpa.The performing physician inadvertently advanced the t20 into the rpa from the mpa without first advancing the dilator.The patient did not report experiencing any pain, nor did the physician notice any resistance while maneuvering the t20.The vert catheter was then removed, an angiogram was performed through the t20 for clot visualization, and an aspiration was performed, removing a small clot.As the t20 was pulled back into the mpa for a final angiogram, contrast indicative of a vessel dissection flap was seen at the junction between the rpa and mpa.No medical or surgical intervention was required to address the dissection flap.The event did not alter the hemodynamics, the flap was not flow-limiting, and the patient's overall condition had improved from the start of the case.The patient's post-procedural vital signs were: heart rate 90 bpm, blood pressure 130/80, mean pulmonary arterial pressure 43/16, and o2 saturation 100% on a non-rebreather mask at 4l o2.The patient had a history of prior chest irradiation that likely increased vessel fragility.The patient was reported to be in stable condition on (b)(6) 2020, with additional clot burden that had been missed on the initial ct and was not caused by treatment with the inari devices.The patient was discharged from the hospital on (b)(6) 2020.A follow-up ct showed no signs of vessel dissection.

• Brand Name: TRIEVER20 CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): INARI MEDICAL, INC.; 9 parker; suite 100; irvine, ca
• MDR Report Key: 10237513
• Report Number: 3011525976-2020-00012
• Device Sequence Number: 13601733
• Product Code: QEW
• UDI-Device Identifier: 00850291007079
• UDI-Public: 00850291007079
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2020

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: 21-101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2020
• Initial Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Weight: 70