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

Model Number	CND0830
Medical Device Problem Codes	Break (1069); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an elective transfemoral carotid stenting procedure, the initial stent delivery system was successfully advanced through the tortuous anatomy.However, during deployment, the stent failed to release.Additional force was applied in an attempt to deploy the stent, at which time the slider component fractured.The device was subsequently removed from the patient, and inspection confirmed that the stent had not deployed.A second stent delivery system was introduced.Due to vessel tortuosity, the physician exchanged the existing 6 fr cook shuttle guiding catheter for a new 6 fr cook shuttle guiding catheter.Prior to deployment, the physician retracted the guiding catheter to help straighten the vessel anatomy.Significant resistance was encountered during deployment, requiring increased force to deploy the stent.The stent was successfully deployed in the intended location.The procedure was completed without reported thrombus formation, embolic complications, or patient injury.
Additional Manufacturer Narrative
See associated mdr 3031658894-2026-00014 for related stent.Device investigation: investigations 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
• MDR Report Key: 25849282
• Report Number: 3032814119-2026-00019
• Device Sequence Number: 10242356
• Product Code: NIM
• UDI-Device Identifier: 07290120281899
• UDI-Public: (01)07290120281899(11)250427(17)260731
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 07/16/2026
• Report Date (Section F): 07/16/2026

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: 07/31/2026
• Device Model Number: CND0830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/18/2026
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2026
• 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: Male
• Date Report Sent to FDA: 07/16/2026