MAUDE Adverse Event Report: INSPIREMD, LTD. CGUARD PRIME CAROTID STENT SYSTEM; CAROTID STENT SYSTEM,

Model Number	CND0940
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis and investigation is in-process.
Event or Problem Description
During the procedure, an 8 fr balloon guide catheter (0.087" inner diameter) was utilized.The left internal carotid artery was predilated twice using an embolic protection device.The physician was able to advance the system to the target lesion and confirmed appropriate device positioning within the anatomy.The safety mechanism was disengaged, and the deployment control was advanced to the pre-release position as intended.During attempted stent deployment, resistance was encountered, and the device could not be released.The system was subsequently removed, and the procedure was completed using an alternative stent system.No patient injury or adverse clinical outcome was reported as a result of this event.

• Brand Name: CGUARD PRIME CAROTID STENT SYSTEM
• Common Device Name: CAROTID STENT SYSTEM,
• Manufacturer (Section D): INSPIREMD, LTD.; 4 menorat hamaor street; tel aviv, 67448 32; IS 6744832
• Manufacturer (Section G): INSPIREMD, LTD.; 4 menorat hamaor street; tel aviv, 67448 32; IS 6744832
• Manufacturer Contact: joselito hernandez ; 4 menorat hamaor street; tel aviv, 67448-32 ; IS 6744832
• MDR Report Key: 24306179
• Report Number: 3031658894-2026-00001
• Device Sequence Number: 20119362
• Product Code: NIM
• UDI-Device Identifier: 07290120281943
• UDI-Public: (01)07290120281943(11)250310(17)260630
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P240029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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 Expiration Date: 06/30/2026
• Device Model Number: CND0940
• Device Catalogue Number: CND0940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• 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: Other
• Patient Age: 82 YR
• Patient Sex: Male