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	09/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device investigation: the device was returned to inspiremd for investigation and the device passed normal production process.Visual inspection of the final product was found to conform to specification.Production records review confirmed the device met all manufacturing specifications, with no malfunction or nonconformance identified.The procedure was completed successfully, and no patient harm or adverse clinical outcome was reported.An investigation was initiated to identify the underlying failure mode(s) associated with delivery system deployment complications which may result in high resistance or inability to deploy the stent.This mdr is being submitted retrospectively as part of corrections implemented through cap-us-006-26 to ensure reporting compliance.At the time of the event, the complaint was assessed as non-reportable; however, the retrospective review determined that the event meets the reporting requirements of 21 cfr part 803 since the reported event may cause or contribute to an adverse event if it were to recur.Inspiremd's recall (recall no.Z-2330-2026), initiated on may 1, 2026, identified a delivery system issue in the cguard® prime carotid stent system.However, this event occurred prior to the initiation of the recall activities.Capa-027-25 has been initiated to further evaluate similar field-reported performance issues, and complaint trending activities remain ongoing.
Event or Problem Description
It was reported that during an elective procedure, the physician was experiencing diffiulty deploying the stent.The physician was able to deploy the stent successfully, and there was no reported patient injury or adverse clinical outcome.

• 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: 25892000
• Report Number: 3032814119-2026-00028
• Device Sequence Number: 18596500
• Product Code: NIM
• UDI-Device Identifier: 07290120281905
• UDI-Public: (01)07290120281905(11)241117(17)260228
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/21/2026
• Report Date (Section F): 07/21/2026

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: 02/28/2026
• Device Model Number: CND0840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/11/2025
• Device Age: 21 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 07/21/2026