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

Model Number	CND0940
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
After getting the cguard into place the physician deployed and heard the click however he could not easily continue deploying the device.He used a competitor's stent and completed the procedure.The physician mentioned it was also very difficult to deploy the competitors stent and said it was the most difficult he had experienced.He did pre-dilate with a 5mm balloon prior ro attempting cguard.There were no complications reported.
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.The results indicate that this lot was processed without incident, and the device conforms to the specifications.A root cause for the difficult deployed stent could not be found and either it was not confirmed that there was a problem with the device, or it was confirmed that there was no problem with the device fda code 67.
Event or Problem Description
After getting the cguard into place the physician deployed and heard the click however he could not easily continue deploying the device.He used a competitors stent and completed the procedure.The physician mentioned it was also very difficult to deploy the competitors stent and said it was the most difficult he had experienced.He did pre-dilate with a 5mm balloon prior ro attempting cguard.There were no complications reported.

• 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: 23974564
• Report Number: 3032814119-2025-00040
• Device Sequence Number: 10704602
• Product Code: NIM
• UDI-Device Identifier: 07290120281943
• UDI-Public: (01)07290120281943(11)250427(17)260731
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 01/06/2026
• Report Date (Section F): 12/09/2025

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 Model Number: CND0940
• Device Catalogue Number: CND0940
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/09/2025
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 04/13/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Unknown