MAUDE Adverse Event Report: InspireMD LTD CGuard Prime Carotid Stent System

Model Number	CND0840
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction

• Brand Name: CGuard Prime Carotid Stent System
• Common Device Name: Carotid Stent System
• Manufacturer (Section D): InspireMD LTD; 4 menorat hamaor street; tel aviv, isr 67448 32; IS 6744832
• MDR Report Key: 50035527
• Report Number: 3032814119-2026-00036
• Device Sequence Number: 13388604
• Product Code: NIM
• UDI-Device Identifier: 07290120281905
• UDI-Public: (01)07290120281905(11)250310(17)260630
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2026
• Report Date (Section F): 07/27/2026

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: CND0840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/11/2025
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/27/2026