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

Model Number	NG-0740-140-2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Event description (as reported).It was reported that a neuroguard stent iep sys ng-0740-140-2 was used to treat a patients right proximal carotid artery, which had a severely calcified lesion with 90% stenosis.Post-op, the patient suffered a stroke (later determined that stroke symptoms started prior to the introduction of the neuroguard device).The patient was admitted to hospital.The issue was resolved.Investigation: summary of conversation between dr.(b)(6) and dr.(b)(6): the target lesion was a heavily calcified 90 percent stenosis of the r ica.An on-label spider distal embolic protection device was deployed without incident.Due to the lesion calcification and degree of stenosis a pre-dilation was performed with a standard angioplasty balloon.Next, due to the severe calcification, an off-label use of shockwave intravascular lithotripsy (ivl) was performed.Importantly, an excessive amount of manipulation of the shockwave catheter was required to deliver the shockwave balloon to the treatment site.During the shockwave (ivl) the patient became symptomatic on the procedure table which was before the neuroguard stent delivery system entered the body.The procedure was completed with the neuroguard device which was used on ifu and performed without any device issues.The patient was admitted to the hospital after the procedure.The admission ct and mri of the brain were both negative for acute stroke.Imaging at hospital day 4 including a repeat ct and mri of the brain did demonstrate findings consistent with an embolic event to the right cerebral hemisphere.The patient did have a mild residual neurologic deficit on the day of discharge.Home.The treating physician said the neuroguard device functioned normally.Conclusions: based on the investigation, the neuroguard iep system performed as intended, with no issues observed during procedure.The stroke symptoms began prior to introduction of the neuroguard device and were attributed to patient-specific factors and procedural complexity, including heavily calcified anatomy and off-label use of the shockwave intravascular lithotripsy (ivl) balloon.There was not an associated neuroguard device malfunction.The device did not contribute to the adverse event.The mdr is being filed as a conservative measure due to peri-procedural stroke and hospitalization, despite normal device performance.

• Brand Name: NEUROGUARD IEP SYSTEM
• Common Device Name: CAROTID STENT SYSTEM
• Manufacturer (Section D): CONTEGO MEDICAL, INC; 3801 lake boone trail,; suite 100; raleigh
• Manufacturer (Section G): CONTEGO MEDICAL; 3801 lake boone trail,; suite 100; raleigh
• MDR Report Key: 24273253
• Report Number: 3011471056-2026-00005
• Device Sequence Number: 13269636
• Product Code: NIM
• UDI-Device Identifier: 00851616007613
• UDI-Public: 00851616007613
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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-0740-140-2
• Device Catalogue Number: NG-0740-140-2
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SHOCKWAVE IVL BALLOON.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown