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

Model Number	NG-0740-140-2
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during treatment of a fibrous lesion in the proximal right internal carotid artery with the neuroguard stent iep sys ng-0740-140-2, there was a delay in surgery of 10 minutes due to the inability to deploy the device.Vessel morphology included 70% stenosis, 15mm length, 6 mm diameter, minimal tortuosity and calcification.A 6f non-contego (cook shuttle) sheath was used.A 6mm spider fx embolic protection device/guidewire was used.The vessel was not pre-dilated or post-dilated and no resistance was encountered when advancing the device.Instructions for use were followed without issue, and the thrumbscrew/lock-pin was checked and removed prior to attempted deployment.No stent struts were exposed or visible on removal, and no intervention was required for removal of the device.The device was safety removed from the patient, and the procedure was completely using a new neuroguard device.No patient complication have been reported as a result of this event.Additional information was received from the rep: the sheath did not retract at all as the thumb wheel was spinning freely.The filter was not exposed as the outer sheath did not retract at all.
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.

• 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: 25480326
• Report Number: 3011471056-2025-00073
• Device Sequence Number: 20178892
• Product Code: NIM
• UDI-Device Identifier: 00851616007613
• UDI-Public: 00851616007613
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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-0740-140-2
• Device Catalogue Number: NG-0740-140-2
• Device Lot Number: Z2460872D
• 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: 10/08/2025
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2025
• 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: 72 YR
• Patient Sex: Female