MAUDE Adverse Event Report: INSPIREMD LLC CGUARD PRIME CAROTID STENT SYSTEM

Model Number	CND0840
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an elective transfemoral carotid intervention performed in a patient with a type ii tortuous aortic arch and a severely calcified ~95% stenotic lesion.Upon advancing of the first stent delivery system, the system failed to deploy.The delivery system was removed, and during handling outside the patient, the handle broke; subsequent manipulation of the nose cone resulted in stent deployment outside the patient.A second stent delivery system was introduced but exhibited the same failure to deploy and was removed without deployment.A third stent delivery system was then advanced and deployed successfully, completing the procedure.The physician reported the deployment lever initially felt normal but became stuck during attempted deployment.No patient injury or adverse clinical outcome was reported.
Additional Manufacturer Narrative
See associated mdr for the initial stent delivery system used during this procedure: 3031658894-2026-00012.This mdr is submitted retrospectively following an fda inspection of inspire md, 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: the device was not returned to inspiremd for investigation.A review of the production records 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.Based on the results of the investigation and available information there is no evidence to suggest the device contributed to an adverse clinical outcome.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 manufactured between february 03, 2025, and february 23, 2026.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 LLC; 4 menorat hamaor street; tel aviv, isr 67448 32; IS 6744832
• MDR Report Key: 25700213
• Report Number: 3032814119-2026-00008
• Device Sequence Number: 9699335
• Product Code: NIM
• UDI-Device Identifier: 07290120281905
• UDI-Public: (01)07290120281905(11)251228(17)270331
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2026
• Report Date (Section F): 07/02/2026

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 Model Number: CND0840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/05/2026
• Device Age: 26 WK
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/02/2026