MAUDE Adverse Event Report: Contego Medical, Inc. Neuroguard IEP System; Stent, Carotid

Model Number	NG-NV-6-30
Medical Device Problem Codes	Premature Activation (1484); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the same procedure, two neuroguard devices malfunctioned.A separate medical device report is being made for each device.This report is for the second one.See report 3011471056-2026-00060 for the first.It was further reported that a second device (ng-nv-6-30 neuroguard stent iep system) was attempted through the same 7fr non-contego catheter as the first device and the same resistance and inability to advance occurred, with the system not advancing past the distal end of the 7f catheter.The resistance was reported to have caused the system wire to buckle through the sheath retraction deployment knob.Resistance in the catheter caused an unsheathe and stent deployment inside the guide catheter.Both the 7fr non-contego catheter and neuroguard were again successfully removed together without patient harm.A 6fr non-contego (penumbra benchmark) catheter and a 7x30 non-contego (cordis precise pro rx) stent were used to complete the procedure without issue.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
The event investigation is still ongoing.A supplemental report will be filed when additional information is available.

• Brand Name: Neuroguard IEP System
• Common Device Name: Stent, Carotid
• Manufacturer (Section D): Contego Medical, Inc.; 3801 lake boone trail; suite 100; raleigh NC 27607
• Manufacturer (Section G): Contego Medical, Inc.; 3801 lake boone trail; suite 100; raleigh NC 27607
• Manufacturer Contact: james clossick ; 3801 lake boone trail, suite 100; raleigh, NC 27607 ; +1(305)607-1708
• MDR Report Key: 50396436
• Report Number: 3011471056-2026-00061
• Device Sequence Number: 21046569
• Product Code: NIM
• UDI-Device Identifier: 00851616007644
• UDI-Public: 00851616007644
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P240009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2026

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-NV-6-30
• Device Catalogue Number: NG-NV-6-30
• Device Lot Number: Z2461012J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2025
• 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
• Patient Age: 66 YR
• Patient Sex: Male