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

Model Number	CND1040
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an elective transfemoral carotid artery stenting procedure, the operator applied "extreme pressure" of th cguard prime stent delivery system to deploy the stent.The stent was able to be deployed successfully, however the stent was deployed covering a portion of the lesion.A secondary inspiremd stent was used to cover the lesion and the procedure was completed without any patient harm.
Additional Manufacturer Narrative
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 # 3032814119-2025-00007.Device investigation: the device was not returned to insiremd for physical analysis, however, the product history 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.Capa-027-25 has been initiated to further evaluate similar field-reported performance issues, and complaint trending activities remain ongoing.In response to the reported deployment-related incident, an investigation was initiated to identify the underlying failure mode(s) associated with delivery system deployment difficulties.A related product recall (recall no.Z-2330-2026) was initiated on may 02, 2026 affecting all 135cm carotid stent systems.All findings and resulting actions will be documented in accordance with established quality system procedures, and updates will be submitted as required.

• 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: 50276333
• Report Number: 3031658894-2026-00067
• Device Sequence Number: 18584821
• Product Code: NIM
• UDI-Device Identifier: 07290120281783
• UDI-Public: (01)07290120281783(11)250210(17)260531
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P240029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 08/17/2026

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: 05/31/2026
• 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: 09/10/2025
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown