MAUDE Adverse Event Report: Contego Medical, Inc. Neuroguard IEP System; Stent, Carotid

Model Number	NG-NV-6-40
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Muscle Weakness/Atrophy (1967)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the neuroguard stent iep system ng-nv-6-40 was implanted in the proximal right internal carotid artery for a severe, calcified 80% stenotic plaque lesion measuring 36mm in length in a 6.8mm vessel in a patient with a history of prior stroke.A non-medtronic (asahi fubuki) sheath was used.Embolic protection was used.The vessel was pre- and post-dilated.No resistance was encountered when advancing the device.The ifu (instruction for use) was followed during preparation, procedure, and post-procedure without issue.The stent was optimally positioned across the target lesion before deployment but migrated north during implantation.The stent remained in the vessel, and two non-medtronic (boston wallstents) were placed to extend.Computed tomography was performed in the procedure room after the procedure and physician confirmed no large-vessel occlusion (lvo) or bleeding.Following placement of the two non-medtronic (boston wallstents) stents, the patient had some left-sided weakness.Integrilin was administered, and the symptoms were improving at the last assessment.The following additional information was later reported: femoral entry route.Embolic protection device: emboshield nav 6, pre-dilation device: boston scientific 3x30 coyote es, post-dilation device: abbott viatrac 14 plus 5x30, size of the asahi fubuki sheath: 6fr 90cm, regarding the migration event: during deployment, the device moved distal, leaving a portion of the proximal lesion uncovered.Where was the neuroguard (i.E., what part of the carotid artery and where in relation to the lesion)? proximal c1 segment.The wallstents were placed proximally.The first one overlapped the neuroguard, and the second one was an extension of the prior wall stent.When asked what was thought to have caused the migration of the neuroguard stent and if there was under sizing of the stent, the reporter speculated, "possibly due to the tight lesion".There was no difficulty during positioning or delivery of the stent system.The neuroguard stent ended up covering some of the distal part of the lesion.When did the patient develop left sided weakness? was it determined post-procedure that the patient had a stroke? reporter stated that it was noticed during an assessment done after the procedure, and that a ct of the head was done in the room"[ed]" and it was determined there was no lvo.What is the current status of the patient? per the fellow as of last week "[the week before the (b)(6)2026]", the patient is "doing much better".The reporter states that the alleged event did not result in a procedural delay.A manufacturer representative was present at the case.Patient has a history of prior stroke, but it is unknown where, and a previously coiled aneurysum.The neuroguard device/delivery system is not available for return as it was discarded by the account.
Additional Manufacturer Narrative
Final results pending completion of investigation.

• 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 ; +1(305)607-1708
• MDR Report Key: 50812889
• Report Number: 3011471056-2026-00076
• Device Sequence Number: 10157593
• Product Code: NIM
• UDI-Device Identifier: 00851616007651
• UDI-Public: 00851616007651
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NG-NV-6-40
• Device Catalogue Number: NG-NV-6-40
• Device Lot Number: Z2461111A
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Female