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

Model Number	NG-NV-6-40
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Event description verbal report from the sales representative who was not present for the case.Physician tried to use neuroguard after re-establishing flow in the ica but the mega ballast sheath prolapsed out of position.Physician decided to remove the neuroguard system and mega ballast together.The physician thinks that when the system approached the groin sheath the neuroguard stent deployed into the descending aorta.Investigation device discarded, no device investigation device possible.There is no report of the neuroguard product malfunctioning.The inadvertent stent deployment appears to be cased by the withdrawal actions related to the removal of the system due to the prolapsed sheath.Suspected primary cause: the most probable contributing factor for the stent deployment was the withdrawal actions (the stent being pulled off by the groin sheath) related to the prolapsed sheath.Conclusions the neuroguard product was used with a mega ballast sheath which prolapsed.Based on the available information, there is no evidence of a neuroguard device malfunction.The unintended removal of the entire system (mega ballast sheath and neuroguard system) created a scenario where the neurogaurd stent was inadvertently deployed by the removal actions used after the mega ballast sheath prolapse.

• Brand Name: NEUROGUARD IEP SYSTEM
• Common Device Name: CAROTID STENT SYSTEM
• Manufacturer (Section D): CONTEGO MEDICAL, INC; 3801 lake boone trail,; suite 100; raleigh CA 27607
• Manufacturer (Section G): CONTEGO MEDICAL; 3801 lake boone trail,; suite 100; raleigh
• MDR Report Key: 24888306
• Report Number: 3011471056-2026-00048
• Device Sequence Number: 9851625
• Product Code: NIM
• UDI-Device Identifier: 00851616007651
• UDI-Public: 00851616007651
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NG-NV-6-40
• Device Catalogue Number: NG-NV-6-40
• Device Lot Number: Z2461021A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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: MEGA BALLAST SHEATH
• Patient Sex: Male