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

Model Number	NG-0740-140-2
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Event description it was reported that during an interventional procedure using the neuroguard stent iep system to treat plaque in the left internal carotid artery with an 80% stenosis (lesion length 30mm, vessel diameter 7mm, moderate tortuosity), a non-medtronic (abbott nav 6) embolic protection device was deployed and the neuroguard system was advanced through a 7fr tour guide sheath.The filter was deployed, the stent was deployed, and post-dilation was performed.After the integrated filter of the neuroguard was closed, the physician was unable to remove the neuroguard delivery system because it would not track back over the nav 6 wire.(this is believed to be due to the tour guide sheath collapsing on the neuroguard device and hindering relative movement).As a result, the physician removed everything as a unit.The delivery system was safely removed successfully without injury/intervention and the procedure was completed.No vessel damage reported.Investigation the device was not returned, but information received suggests that the reported situation may have been related to use of a tour guide sheath that broke during the procedure.The lot history does not indicate production related anomalies associated with product lot.There is not a complaint history associated with this report.Suspected primary cause: the reported event is consistent with a kink and or buckle of the tour guide sheath which then collapsed on the neuroguard product.This buckle or kink then did not allow the neuroguard to move with respect to the tour guide.The system then was removed as a unit.Conclusions there was no malfunction identified in the contego neuroguard product.There were no patient complications or additional interventions required as result of the event.The contego investigation does not indicate manufacturing related causes for the reported event.The neuroguard device does not have a complaint history for this type of event.The reported event is consistent with an accessory product kinking or buckling on the neuroguard, causing the entire system to be removed as one unit.

• Brand Name: NEUROGUARD IEP SYSTEM
• Common Device Name: CAROTID STENT
• Manufacturer (Section D): CONTEGO MEDICAL, INC; 3801 lake boone trail,; suite 100; raleigh
• Manufacturer (Section G): CONTEGO MEDICAL; 3801 lake boone trail,; suite 100; raleigh
• MDR Report Key: 25062451
• Report Number: 3011471056-2026-00067
• Device Sequence Number: 15977856
• Product Code: NIM
• UDI-Device Identifier: 00851616007613
• UDI-Public: 00851616007613
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/01/2026

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-0740-140-2
• Device Catalogue Number: NG-0740-140-2
• Device Lot Number: Z2460872D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 05/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown