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
Event or Problem Description
It was reported that during an transfemoral case in the left internal carotid artery, the physician had significant trouble retracting the blue slider.The stent deivery system experienced difficulty deploying the stent.The stent deployed successfully, and the procedure was completed without any patient harm.
Additional Manufacturer Narrative
Device investigation: the device was not returned to inspiremd for investigation, however, production records review confirmed the device met all manufacturing specifications, with no malfunction or nonconformance identified.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.

• 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
• Manufacturer (Section G): InspireMD Ltd.; 4 menorat hamaor street; tel aviv, isr 67448 32; IS 6744832
• Manufacturer Contact: magaly boardman ; 4 menorat hamaor street; tel aviv, isr 67448-32 ; IS 6744832
• MDR Report Key: 50000122
• Report Number: 3031658894-2026-00041
• Device Sequence Number: 16048025
• 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
• PMA/510(K) Number: P240029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/22/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2330-2026
• Patient Sequence Number: 1
• Patient Sex: Unknown