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

Model Number	NG-0640-140-2
Medical Device Problem Codes	Use of Device Problem (1670); Device Damaged by Another Device (2915); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Vent description: a physician used a ng-0640-140-2 neuroguard stent iep system for the treatment of a plaque lesion in the patient's distal left common carotid artery.Minimal vessel tortuosity and calcification were reported.A 90cm 6fr non-medtronic (flexor checkflow) sheath and a spider fx guidewire/embolic protection device were used.The ifu (instruction for use) was followed during preparation, procedure, post-procedure without issue.The vessel was pre-dilated.No resistance was encountered when advancing the device.It was reported that the integrated distal embolic protection filter would not open once the system was inserted in the body.The filter was working during prep of the device but failed to open once inserted across lesion.The physician deployed stent without integrated embolic filter open.Post-dilatation was performed with the balloon mounted on neuroguard system and the procedure was completed.The device was safely removed from the patient.The stent remains implanted in patient.No patient complications have been reported as a result of this event.Investigation: the activation wire separated from the distal collar.The investigation was unable to determine the root cause of the separation.Suspected primary cause: axial load on the actuation wire exceeded the strength of the actuator connection.Conclusions: the procedure was successfully completed, with the primary distal filter in place.The integrated filter opened during device preparation but was unable to open once device crossed the lesion.No patient complications resulted as of this reported event.

• 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 ; 3056071708
• MDR Report Key: 24719206
• Report Number: 3011471056-2026-00039
• Device Sequence Number: 12265171
• Product Code: NIM
• UDI-Device Identifier: 00851616007590
• UDI-Public: 00851616007590
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2026

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-0640-140-2
• Device Catalogue Number: NG-0640-140-2
• Device Lot Number: Z2460909K
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 05/22/2025; 02/26/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/11/2026; 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2025
• 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: 3011471056/06252026/R/00
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Unknown
• Patient Weight: 75 KG