MAUDE Adverse Event Report: INARI MEDICAL, INC. CLOTTRIEVER XL CATHETER; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	41-102
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Abdominal Pain (1685); Low Blood Pressure/ Hypotension (1914); Great Vessel Perforation (2152); Abdominal Distention (2601)
Date of Event	01/31/2024
Type of Reportable Event	Death
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.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 venous cutdown was the result of device entrapment in the vessel.The thrombus size and prior radiation treatment may have contributed to the event.Inferior vena cava thrombosis is associated with high morbidity.Vessel dissection and hemorrhage are identified in the labeling as possible adverse events/complications.Manufacturer reference#: (b)(4).
Event or Problem Description
A 71-year-old female patient with a history of breast cancer presented to the emergency department with worsening abdominal pain and bloody stool.A computed tomography (ct) scan was performed which revealed inferior vena cava (ivc) thrombus from the renal vein extending down to the confluence.The clot age was estimated at 2 days.The patient was scheduled for a thrombectomy on (b)(6) 2024 using the inari clottriever thrombectomy system.After imaging was performed, the clottriever (ct) sheath 16 fr was placed.Access and wire positioning were obtained without issue.The clottriever xl (ctxl) catheter was advanced into place with the bullet tip placed proximal to the thrombus.A single pass was performed when the patient reported experiencing abdominal pain.The physician attempted to remove the ctxl catheter from the ct sheath but was unable to.Fluoroscopy revealed the coring element was within the ct sheath, but the proximal aspect of the bag was full with thrombus and appeared to be extending out of the sheath funnel.Various attempts were made to remove the ctxl (re-sheathing the ctxl with the outside catheter portion, advancing the catheter back proximally, and removing both devices as a unit), but none were successful.The patient's blood pressure (bp) decreased from a baseline of 136/72 mmhg to 66/50 mmhg; intravenous fluids and epinephrine were administered, and bp improved to 91/67 mmhg.A decision was made to transfer the patient to another hospital for an emergency venous cutdown/exploratory procedure.While waiting for the flight crew, imaging was performed and there was no evidence of extravasation but the bladder was slightly distended and a hemorrhage was suspected.Prior to the hospital transfer, the patient was alert and in stable condition.Patient follow-up revealed that the patient expired later that evening during the exploratory procedure.

• Brand Name: CLOTTRIEVER XL CATHETER
• 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: 18805241
• Report Number: 3020347218-2024-00010
• Device Sequence Number: 12605564
• Product Code: QEW
• UDI-Device Identifier: 00850291007277
• UDI-Public: 00850291007277
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K223210
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2025
• Device Model Number: 41-102
• Device Lot Number: 23080001
• 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: 01/31/2024
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2023
• 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: CLOTTRIEVER SHEATH 16 FR.; GWA 260 CM AND CATHETER.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening; Death
• Patient Age: 71 YR
• Patient Sex: Female