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

Model Number	NG-NV-6-40
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a calcified lesion exhibiting moderate calcification and minimaltortuosity in the mid right carotid artery underwent right carotid artery stent placement using the neuroguard ng-nv-6-40 stent.The physician navigated a non-medtronic (walrus) balloon guide catheter to the right common carotid arteryand a non-medtronic (aristotle 14) guidewire to the right internal carotid artery.The physician elected to not use adistal protection device in this case.The neuroguard was then prepped according to the ifu.The physician elected to not inflate the balloon guide catheter the entire case.The physician then tracked neuroguard to the lesion.Theguidewire was having trouble staying distal and had reduced purchase distal to the tip of the neuroguard byapproximately 2 or 3cm.The rep then instructed the physician on how to start deploying the device.He used the thumbwheel to unsheath the blue outer sheath to the distal tip of the stent and expose the filter.At this time the rep instructedphysician to use the rotation knob to open the filter.The physician elected to not use the filter and wanted to go aheadwith stent deployment.Physician finished deploying the stent without the filter exposed.The physician then post-dilated with the integrated balloon to a nominal pressure of 8atm.Once the balloon was deflated, he removed thedevice from the patient.The procedure was completed successfully with no injury reported from the procedure itself.Days after the procedure, the patient experienced a left-sided stroke, which was still present at the time of reporting.The physician believed the neuroguard stent did not cause the stroke.No medical or surgical intervention was required for the stroke.It was stated that images are not available.The physician has explicity request he is not contacted regarding this report.Additional information was received from the rep i was present for the case and was supporting the physician and our device.The physician navigated a walrus balloon guide catheter to the right common carotid artery and an aristotle 14 guidewire to the right internal carotid artery.The physician elected to not use a distal protection device in this case.The neuroguard was then prepped according to the ifu.The physician elected to not inflate the balloon guide catheter the entire case.The physician then tracked neuroguard to the lesion.The guidewire was having trouble staying distal and had reduced purchase distal to the tip of the neuroguard - maybe 2 or 3cm.I then instructed the physician on how to start deploying the device.He used the thumb wheel to unsheath the blue outer sheath to the distal tip of the stent and expose the filter.At this time, i instructed him to use the rotation knob to open the filter.The physician elected to not use the filter and wanted to go ahead with stent deployment.Physician finished deploying the stent w/o the filter exposed.The physician then post dilated with the integrated balloon to a nominal pressure of 8atm.Once the balloon was deflated, he removed the device from the patient.Case was completed successfully.I was notified by the physician on (b)(6) 2026 that the patient had experienced a stroke on the left side.The physician believed neuroguard did not cause the stroke.The physician has requested he is not contacted regarding this matter.Additional information was received from the distributor on 14-apr-2026: this was the physician's first or second case; he was in-serviced; although it was not clarified what this meant.The mpxr reports "left sided" stroke which can imply the symptomatic side of the patient or the affected side of the brain.To clarify in this case, the cva that occurred between days 0 and 4 post-procedure was in the contralateral hemisphere (lt brain), where was therefore most likely procedural related.There were no patient anatomic reasons why the integrated filter was not used in vivo, nor the walrus catheter inflated.There was no primary filter used.The site has been further in-serviced on the proper use of the device and the physician has used the device several times since.Unclear of the patient's status at discharge or currently.Below information previously received but also discussed on the call.Patient had left side 99% stenosis, but physician decided to treat right side instead, which was great than 80% stenosis.Physician was happy with results of procedure with neuroguard on the side that was treated.The rep went back into lab on (b)(6) 2026 to do an inservice on a different product, when the lab staff happened to mention that the patient we treated had a stroke sometime post-procedure.The rep then followed up with the physician who firmly stated that the neuroguard procedure had notion to do with the patient's stroke on the opposide side of where we treated.Physician reiterated our device had noting to do with the stroke event.Physician does not want to be contacted again because he sees no correlation between neuroguard procedure and stroke event.The rep is unable to get response from physician as to why he treated off-label as he did.The rep is working with physician and staff to redo inservice to further enforce on-label usage.
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: jim clossick ; 3801 lake boone trail; suite 100; raleigh, NC 27607
• MDR Report Key: 25459588
• Report Number: 3011471056-2026-00053
• Device Sequence Number: 10363341
• 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): 06/10/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: NG-NV-6-40
• Device Catalogue Number: NG-NV-6-40
• Device Lot Number: Z2460963P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown