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

Model Number	NG-0730-140-2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Muscle Weakness/Atrophy (1967); Transient Ischemic Attack (2109); Dysphasia (2195); Ischemia Stroke (4418)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Event description: a physician used a neuroguard stent iep system for patient treatment.The treated segment wasn't overly calcific.The common carotid artery (cca) into internal carotid artery (ica) was straight.The distal ica did have a loop.A 5 mm spider fx embolic protection device was in place right before the ica looped.The device was prepped per the instructions for use (ifu).A 7fr non-medtronic (terumo) sheath was used.There were no other devices used.The procedure went well, everyone was happy, patient was good.However, the patient had an embolic stroke 10 hours post procedure and fully recovered the following day.Physician said the stent and vessel look fine, and he is not sure where the embolic event came from.No further patient injury reported for this event.Investigation: on 12feb2026, additional information from dr.(b)(6): dr.(b)(6) spoke with the physician (summary).Further information obtained from the physician: patient was an asymptomatic 70-year-old male.Ashd w stents.Pad w stents.Atrial fib (eliquis appropriately held).Remote stroke from afib.Progressive carotid artery stenosis on lica.The carotid stent procedure "went very well".Bradycardia with post dilation.Stroke alert 10 hours after procedure.Right upper ext weakness, aphasia.Initial cta/ct brain- ng stent widely patent.No stroke.No large vessel occlusion.Mri next day: consistent w embolic shower left sided.Small hemorrhagic changes.Patient in hospital for 5 days: started pt/ot.Discharged to rehab facility with mild expressive aphasia and right upper ext weakness resolved.Suspected primary cause: idiopathic minor stroke with possible relationship to preexisting conditions including afib and prior cerebrovascular history.Conclusions no evidence of device malfunction or performance deficiency was identified.Reported symptoms most likely related to preexisting conditions.This event is being filed as an mdr as a conservative measure.
Event or Problem Description
On (b)(6)2026, it was reported that a physician used a neuroguard stent iep system for patient treatment.The treated segment wasn't overly calcific.The common carotid artery (cca) into internal carotid artery (ica) was straight.The distal ica did have a loop.A 5mm spider fx embolic protection device was in place right before the ica looped.The device was prepped per the instructions for use (ifu).A 7fr non-contego (terumo) sheath was used.There were no other devices used.The procedure went well, everyone was happy, patient was good.However, the patient had an embolic stroke 10 hours post procedure and fully recovered the following day.Physician said the stent and vessel look fine, and he is not sure where the embolic event came from.No further patient injury reported for this event.Additional information was received from the treating physician on (b)(6) 2026: 70 year old male, asymptomatic, ashd w stents.Pad w stents.Atrial fib (eliquis appropriatly held).Remote stroke from afib (date not known, but very remote).Progressive carotid artery stenosis on lica.The carotid stent procedure "went very well." 40 minutes total time.Interventional sheath tracked very easy.Spider epd no issues.Ng - "worked great." bradycardia with post dilation.Patient fine when dr.Xxxx rounded end of day.Stroke alert 10 hours after procedure.Right upper extremity weakness, aphasia.Initial cta/ct brain - ng stent widely patent.No stroke.No large vessel occlusion.Mri next day - consistent with embolic shower left sided.Small hemorrhagic changes.Patient in hospital for 5 days - started pt/ot.Discharged to rehab facility with mild expressive aphasia and right upper extremity weakness resolved.Dapt pre-procedure per protocol.Dr.Xxxx has "no idea" what could have happened - procedure was without incident and went fast and easy.Additional information was received on february 16, 2026: it was reported that the patient had aphasia 12 hours after the procedure with stroke/transient ischaemic attack (tia) indicated on imaging.Stent and vessel were widely patient and no source was identified.Symptoms resolved the next morning.No medical or surgical intervention was required.The calcified plaque lesion was located in the patients left proximal internal carotid artery (ica).Lesion exhibited >70% stenosis.
Additional Manufacturer Narrative
This form 3500a is being corrected to amend the original submission dated 03/06/2026, where the malfunction box was incorrectly selected instead of serious injury.

• 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
• Manufacturer Contact: james clossick ; 3801 lake boone trail,; suite 100; raleigh, NC 27607 ; 3056071708
• MDR Report Key: 24536672
• Report Number: 3011471056-2026-00025
• Device Sequence Number: 21425591
• Product Code: NIM
• UDI-Device Identifier: 00851616007606
• UDI-Public: 00851616007606
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2026

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-0730-140-2
• Device Catalogue Number: NG-0730-140-2
• Device Lot Number: Z2461012F
• 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): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 06/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown