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

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	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: a physician was attempting to use a neuroguard device to treat the left mid common carotid reported to be calcified with minimal tortuosity.During deployment of the neuroguard stent iep sys ng-0740-140-2, the filter did not open fully upon initial deployment.The device was prepped as per ifu with no issues noted.An embolic protection device was used, but model is unknown.Same device used once filter fully opened on it's own.There was no health consequences or impact to patient for this event.Investigation preliminary: the preliminary investigation determined that unknown source caused a deformation of the outer body.The deformation is consistent with heat damage.This is a new and unique failure mode.The failure mode potentially results in impingement on the movement (both directions) of the filter actuation wire.Conclusions: the deformation of the outer body caused additional friction in the filter wire actuation led to a slow opening and closing filter.

• Brand Name: NEUROGUARD IEP SYSTEM
• Common Device Name: CAROTID STENT SYSTEM
• 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: 24085773
• Report Number: 3011471056-2025-00100
• Device Sequence Number: 15896661
• Product Code: NIM
• UDI-Device Identifier: 00851616007583
• UDI-Public: 00851616007583
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/15/2026

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: Z2460909I
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2026
• 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