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

Model Number	NG-NV-7-40
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is a remedial submission made in direct response to fda form 483 observations to ensure full reporting compliance.The associated complaint was originally classified as non-reportable; however, following a retrospective reassessment, the manufacturer determined that the event meets the reportability criteria under 21 cfr part 803.This submission fulfills our commitment to correct the initial reporting determination.
Event or Problem Description
Limited information was reported that when the physician went to deploy the neuroguard stent isp sys nv-nv-7-40, the stent would not deploy.Physician kept using the thumb wheel to deploy but the stent was not coming out.No patient complications have been reported as a result of this event.Additional information was received: dr.Xxx was treating an internal carotid artery stenosis with the neuroguard.The neuroguard was advanced to the target lesion.The 40 micron filter was deployed.When attempting to next deploy the neuroguard stent, the thumbwheel did not move, the neuroguard filter was closed and the neuroguard delivery system was removed from the circulation without difficulty.A new neuroguard was then used to treat the patient and performed without any issues.There were no patient complications.

• 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 ; 3056071708
• MDR Report Key: 25476891
• Report Number: 3011471056-2026-00003
• Device Sequence Number: 21123289
• Product Code: NIM
• UDI-Device Identifier: 00851616007620
• UDI-Public: 00851616007620
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/11/2026

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-7-40
• Device Catalogue Number: NG-NV-7-40
• Device Lot Number: Z2460909H
• 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: 04/03/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2025
• 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 Sex: Unknown