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

Model Number	FG11815
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 - date of event: event date was not provided but was estimated based on stroke occurring approximately two weeks following the procedure.
Event or Problem Description
It was reported that the patient had a stroke post procedure.An enroute transcarotid stent was selected for use in the left transcarotid artery revascularization (tcar) procedure.It was reported that approximately two weeks after the procedure, the patient had a stroke.The patient was admitted to the hospital beyond the standard of care.The symptoms have not been resolved yet.At this time, the etiology of the stroke and whether any intervention was performed are unknown.No further information was available to boston scientific.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23646297
• Report Number: 2124215-2025-85151
• Device Sequence Number: 15983601
• Product Code: NIM
• UDI-Device Identifier: 00811311021314
• UDI-Public: (01)00811311021314(17)280131(10)18415391
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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: FG11815
• Device Catalogue Number: FG11815
• Device Lot Number: 0018415391
• 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: 10/31/2025
• Initial Report FDA Received Date: 11/25/2025
• Date Device Manufactured: 02/17/2025
• 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
• Patient Sex: Male