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	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis and investigation is in-process.
Event or Problem Description
It was reported that during an intervention of a patient experiencing clots, dissection and calcification in the carotid, the physician decided to use a cnd1040.The physician was able to advance into the lesion, but during deployment, resistance was experienced, and the stent did not deploy.The physician decided not to continue applying force into the delivery system and proceeded to remove the catheter/stent.The physician finished the procedure with a competitor stent.No harm to the patient reported.After the procedure, the physician tried to deploy the stent in a flat table.Stent deployed.
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 non-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
It was reported that during an intervention of a patient experiencing clots, dissection and calcification in the carotid, the physician decided to use a cnd1040.The physician was able to advance into the lesion, but during deployment, resistance was experienced, and the stent did not deploy.The physician decided not to continue applying force into the delivery system and proceeded to remove the catheter/stent.The physician finished the procedure with a competitor stent.No harm to the patient reported.After the procedure, the physician tried to deploy the stent in a flat table.Stent deployed.

• 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: 23466394
• Report Number: 3032814119-2025-00021
• Device Sequence Number: 10088964
• Product Code: NIM
• UDI-Device Identifier: 07290120281981
• UDI-Public: (01)07290120281981(11)250210(17)260531
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/04/2025
• Report Date (Section F): 10/09/2025

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: CND1040
• Device Catalogue Number: CND1040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/09/2025
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2025
• 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