MAUDE Adverse Event Report: SILK ROAD MEDICAL ENROUTE TRANSCAROTID STENT; STENT, CAROTID

Model Number	SR-1040-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Convulsion/Seizure (4406); Restenosis (4576); Reperfusion Injury (4851)
Date of Event	03/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was narrowing in the stent at the distal segment, requiring medication.An enroute transcarotid stent was selected for use in a left side transcarotid artery revascularization (tcar) procedure.It was reported that four days after a tcar procedure, the patient went to another hospital with stroke and seizure.Imaging performed suggested an acute posterior temporal cerebrovascular accident (cva).The stent was patent.Further information indicated that imaging showed no left sided cva and confirmed the findings represented an old stroke, with no thrombus present in the stent.The physician believed this was a post reperfusion seizure.The patient is neurologically intact.It was also noted that there was narrowing in the stent at the distal segment where the internal carotid artery (ica) was stenosed prior to the tcar procedure.Eliquis was recommended for the patient.At this time, it is not confirmed if the medication was given due to restenosis or possible atrial fibrillation.

• Brand Name: ENROUTE TRANSCAROTID STENT
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL INC.; 27th ave north plymouth; minneapolis MN 55447
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24932870
• Report Number: 2124215-2026-21348
• Device Sequence Number: 5168016
• Product Code: NIM
• UDI-Device Identifier: 00811311020539
• UDI-Public: (01)00811311020539(17)280331(10)18437819
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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 Model Number: SR-1040-CS
• Device Catalogue Number: SR-1040-CS
• Device Lot Number: 0018437819
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 06/30/2026
• Date Device Manufactured: 04/09/2025
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male