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

Model Number	NG-0740-140-2
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were no patient injuries, sequelae or adverse events.
Event or Problem Description
During a carotid artery stenting procedure, the physician experienced inconsistent deployment of the neuroguard filter.While no adverse clinical outcome was reported, a possible potential performance variation was experienced.The neuroguard filter did not fully open upon retraction of the outer sheath and full actuation of the filter wheel, resulting in incomplete filter apposition until after partial or full stent deployment.It should be noted that a distal primary filter is required to be in place as per the ifu.The contego filter opening challenges could lead to minor procedural delays, device removal, or the need to use alternative stents.No adverse patient outcomes were reported, and are not anticipated.

• Brand Name: NEUROGUARD IEP SYSTEM
• Common Device Name: CAROTID STENT SYSTEM
• Manufacturer (Section D): 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: 22613488
• Report Number: 3011471056-2025-00037
• Device Sequence Number: 17489031
• Product Code: NIM
• UDI-Device Identifier: 00851616007613
• UDI-Public: 00851616007613
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

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: Z2460766A
• 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: 05/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0131-2026
• Patient Sequence Number: 1
• Patient Sex: Unknown