MAUDE Adverse Event Report: InspireMD Ltd. CGuard Prime Carotid Stent System

Model Number	CND1040
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a trans ulnar access case, the physician experienced a non-deployment using the cguard prime carotid stent system 135cm.The physician attempted to use a secondary cguard prime carotid stent system 135cm using the trans femoral approach, however the issue persisted.A competitor stent was used to complete the procedure successfully with no reported patient harm.The system was able to be deployed outside of the patients body.
Additional Manufacturer Narrative
See additional manufacturer report #s for secondary device used during the same procedure: 3031658894-2026-00060 and uf/importer report # 3032814119-2025-00015.This mdr is being submitted retrospectively as part of capa-us-002-26, identified during a retrospective review conducted under the capa.See related importer report # 3032814119-2025-00016.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.The procedure was completed using a competitor stent, 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.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 LLC; 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: 50148447
• Report Number: 3031658894-2026-00059
• Device Sequence Number: 13439005
• Product Code: NIM
• UDI-Device Identifier: 07290120281981
• UDI-Public: (01)07290120281981(11)241117(17)260228
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P240029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: CND1040
• 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: 08/21/2025
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male