MAUDE Adverse Event Report: CONTEGO MEDICAL, INC NEUROGUARD IEP SYSTEM; STENT, CAROTID

Model Number	NG-0640-140-2
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a neuroguard stent iep system was used to treat a left proximal and distal common carotid artery and internal carotid artery fibrous lesion with 85-90% stenosis, an approximate length of 20mm, and minimal vessel tortuosity.Common carotid artery diameter reported as 7-7.3mm, and the internal carotid artery diameter reported as 4.5- 5.2mm.A 6 fr non-medtronic (cook shuttle) sheath, and a 6mm 0.014 spider fx embolic protection/guidewire were used.Prior to procedure, staff was inserviced and questions/concerns addressed.The vessel was pre-dilated with a 3mm x 20mm non-medtronic (boston sci emerge) balloon catheter, and post-dilatation with the neuroguard integrated balloon system.During the procedure, the neuroguard was prepped, and deployed per instructions for use (ifu).During post-dilatation with the neuroguard system, the patient experienced a significant baroreceptor response and emergency intervention from team was required to stabilize the patient.Simultaneously, the rep observed that the physician was going to manipulate the device and advised her to stop because the secondary filter was still open, she was advised to close the filter before any manipulations we made.This was done and the device was removed smoothly.Medical intervention was required and the patient was prescribed atropine, neo-synephrine and epinephrine iv.The patient was admitted to the hospital.After case completion, review of images identified stent deformation in vivo, described as deformed stent struts with a malformed distal stent segment that was partially not apposed to the wall of the internal carotid artery, and the physician was informed.Follow-up imaging with cta was planned to evaluate the stent, with possible return to the lab for evaluation and potential corrective intervention(s).

• Brand Name: NEUROGUARD IEP SYSTEM
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): CONTEGO MEDICAL, INC; 3801 lake boone trail,; suite 100; raleigh NC
• Manufacturer (Section G): CONTEGO MEDICAL; 3801 lake boone trail,; suite 100; raleigh NC
• MDR Report Key: 25402422
• Report Number: 3011471056-2026-00096
• Device Sequence Number: 18671998
• Product Code: NIM
• UDI-Device Identifier: 00851616007590
• UDI-Public: 00851616007590
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P240009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

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 Model Number: NG-0640-140-2
• Device Catalogue Number: NG-0640-140-2
• Device Lot Number: Z2460948I
• 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: 05/05/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2025
• 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: ATROPINE; EPINEPHRINE; NEO-SYNEPHRINE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male