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

Model Number	44-101
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, a 39-year-old male patient underwent a deep vein thrombosis (dvt) thrombectomy using inari devices.The patient had preexisting stents placed in the left common iliac and the left external iliac veins.The clot age was estimated at 21 days.During the thrombectomy, the revcore catheter became caught on one of the patient's preexisting stent struts but the entire device was able to be resheathed and removed from the patient.Balloon angioplasty and intravascular ultrasound (ivus) did not show any issues with the patient's stent and the procedure was completed without incident with approximately 100% clot removed.The patient returned approximately one week post-procedure and presented with swelling.A computed tomography (ct) scan revealed no injury to the patient's vein, but the patient had re-thrombosed and a stent strut was broken.The patient was then treated with lyrics and a second stent was placed.
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 have been no similar complaint events for this lot number.The device labeling includes the following warning statements: "when revcore is in the path of an exposed stent with broken/fractured struts, a stent <10mm in diameter, or a stent compressed to <10mm, damage to the stent, the coring element, or dislodgment of the stent, etc.May occur." "avoid using excessive force to advance or retract against resistance.If excessive resistance is encountered, retract, and collapse the coring element into the outer catheter and remove the device.Excessive force against resistance may result in damage to the device or vessel." "examine the revcore thrombectomy catheter prior to insertion to verify it is not damaged," "proceed with caution when using revcore in or near a recently deployed stent.The revcore thrombectomy catheter has not been tested for post-dilatation of stents." "before inserting the catheter for use in patients with stents, ensure the guidewire is properly placed, and not threaded or entangled in the wire mesh or lining of the stent." manufacturer reference: (b)(4).

• Brand Name: REVCORE THROMBECTOMY 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
• MDR Report Key: 20898131
• Report Number: 3020347218-2024-00049
• Device Sequence Number: 21106444
• Product Code: QEW
• UDI-Device Identifier: 00850291007383
• UDI-Public: 00850291007383
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K223609
• 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): 12/10/2024

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: 09/24/2026
• Device Model Number: 44-101
• Device Lot Number: 24090109
• 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: 11/11/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2024
• 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, 13 FR; FLOWSAVER; PROTRIEVE SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male