MAUDE Adverse Event Report: INSPIREMD LTD. CGUARD PRIME CAROTID STENT SYSTEM

Model Number	CND0830
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a transfemoral procedure, the physician experienced difficulty advancing the device through the iliac artery into the aorta.Upon reaching the target location, increased resistance was encountered during the deployment sequence.The device failed to deploy, and the deployment lever became damaged when additional force was applied.The physician subsequently attempted to deploy the stent on the back table; however, deployment was unsuccessful.The procedure was completed using a competitor stent (acculink), which was successfully deployed.No patient injury or adverse clinical outcome was reported.
Additional Manufacturer Narrative
This mdr is submitted retrospectively following an fda inspection of inspiremd, inc.(fei# 3032814119) concluded on june 18, 2026, during which a form fda 483 was issued citing failure to submit mdrs within 30 calendar days, in accordance with 21 cfr part 803.Inspectional feedback also clarified expectations for initiating mdrs for adverse events, including device malfunctions.In parallel, inspiremd's recall identified a delivery system issue in the cguard® prime carotid stent system related to deployment resistance, which under certain conditions may result in failure to deploy or incomplete lesion coverage.The events described herein involve device malfunctions during procedures that were not previously reported within required timelines per internal operating procedures.In response, inspiremd conducted a retrospective review of complaints associated with deployment resistance.Events previously deemed non-reportable were reassessed using expanded reportability criteria communicated during the inspection and were determined to be reportable regardless of clinical outcome or confirmed causality.This report is submitted outside the 30-day timeframe due to identification of reportability following the inspection (june 18, 2026).This submission is part of corrective actions to address the observation, strengthen mdr processes, and enhance regulatory compliance.Device investigation: investigations 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.A related product recall (recall no.Z-2330-2026) was initiated on may 01, 2026 affecting all 135cm carotid stent systems.However, this event occurred prior to the initiation of the recall activities.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: 25686468
• Report Number: 3031658894-2026-00011
• Device Sequence Number: 14620425
• Product Code: NIM
• UDI-Device Identifier: 07290120281899
• UDI-Public: (01)07290120281899(11)250203(17)260531
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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: 05/31/2026
• Device Model Number: CND0830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Female