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

Model Number	CND1040
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the following: physician was able to complete the procedure.Patient is doing well; however, the nose of the stent post deployment wa getting stuck prior ro post dilation.He used a 3.5 balloon free in a moderately calcified lesion, followed with a 5.5 balloon.During the deployment process the stent did jump but did not mis the (stenosis) lesion, however it did not deploy at the desired location and had to expand the stent.The physician used a ompetitor stent to cover the proximal common carotid.The physician did not expereince resistance.The nose cone is bulky per physician.
Additional Manufacturer Narrative
Device analysis and investigation is in-process.
Event or Problem Description
It was reported the following: physician was able to complete the procedure.Patient is doing well; however, the nose of the stent post deployment wa getting stuck prior ro post dilation.He used a 3.5 balloon free in a moderately calcified lesion, followed with a 5.5 balloon.During the deployment process the stent did jump but did not mis the (stenosis) lesion; however, it did not deploy at the desired location and had to expand the stent.The physician used a competitor stent to cover the proximal common carotid.The physician did not experience resistance.The nose cone is bulky per physician.
Additional Manufacturer Narrative
Device analysis and investigation is in-process.Supplemental follow up report: a root cause investigation was conducted for this event.The device was not returned for analysis.An internal lot record review was performed.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.

• 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: 23803692
• Report Number: 3032814119-2025-00029
• Device Sequence Number: 9360032
• Product Code: NIM
• UDI-Device Identifier: 07290120281981
• UDI-Public: (01)07290120281981(11)250427(17)260731
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/15/2025
• Report Date (Section F): 11/21/2025

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: CND1040
• Device Catalogue Number: CND1040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/21/2025
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 05/19/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown