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

Model Number	CND0830
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The device was delivered successfully to the lesion; however, the device would not deploy due to significant resistance of the blue deployment slider.The blue deployment would not pull back.The stent was removed successfully and an alternative stent from a different company was selected, delivered and deployed successfully.There was no patient impact.
Additional Manufacturer Narrative
Device analysis and investigation is in-process.
Additional Manufacturer Narrative
Device analysis and investigation is in-process.Supplemental follow up report.A root cause investigation was conducted for this event which included a returned product visual and functional analysis, internal lot record review, and clinical case imaging review.The results indicate that this lot was processed without incident, and the device conforms to the specifications.A root cause for the non-deployed stent could not be found and the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event fda code 4315.
Event or Problem Description
The device was delivered successfully to the lesion; however, the device would not deploy due to significant resistance of the blue deployment slider.The blue deployment would not pull back.The stent was removed successfully and an alternative stent from a different company was selected, delivered and deployed successfully.There was no patient impact.

• 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
• MDR Report Key: 23144653
• Report Number: 3032814119-2025-00002
• Device Sequence Number: 9856935
• Product Code: NIM
• UDI-Device Identifier: 07290120281899
• UDI-Public: (01)07290120281899(11)250210(17)260531(17)260531
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2025
• Report Date (Section F): 08/25/2025

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: 05/31/2026
• Device Model Number: CND0830
• Device Catalogue Number: CND0830
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/27/2025
• Date Report to Manufacturer: 08/25/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 12/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown