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

Model Number	CND0840
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	01/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a transcarotid artery revascularization (tcar) procedure with implantation of a cguard prime carotid stent 135 and subsequently experienced a neurological event.The physician confirmed a stroke through physical neurological examination findings, computed tomography angiography (cta), and magnetic resonance imaging (mri) performed the day following the procedure.Additional information was received on (b)(6), 2026 indicating that according to the physician, the patient's neurological symptoms returned to baseline during the subsequent week.
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.It was reported that the device was utilized during a transcarotid artery revascularization (tcar) procedure.Tcar is not an approved indication for use of the cguard prime carotid stent system 135cm in the united states and therefore represents off-label use of the device.Based on the information received and the results of the investigation, no device malfunction, manufacturing deficiency, or device mechanism-related issue was identified.A definitive root cause could not be determined.The reported event is a known potential adverse event associated with carotid artery stenting and may also be influenced by patient, lesion, procedural, or other clinical factors.Complaint trending and post-market surveillance activities are performed on an ongoing basis.Appropriate actions will be evaluated and implemented should an increase in similar events be identified.The cguard prime 135 cm delivery system instructions for use (ifu), include the following warning: "the stent systems may cause thrombus migration from the implant site along the arterial lumen and may produce distal embolization.".

• 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: 50124750
• Report Number: 3031658894-2026-00052
• Device Sequence Number: 5597810
• Product Code: NIM
• UDI-Device Identifier: 07290120281905
• UDI-Public: (01)07290120281905(11)250317(17)260630
• 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
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: CND0840
• 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: 01/02/2026
• Initial Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2025
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown