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

Model Number	SR-0730-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a dissection was identified resulting in an additional stent placement.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.During the tcar procedure, the physician advanced the 0.014" guidewire into the internal carotid artery (ica), pre-dilated, placed an enroute stent, and post-dilated successfully.Imaging was then performed, and it revealed a dissection just beyond the distal portion of the stent in the ica.The physician attributed the dissection event to either the enroute 0.014" guidewire or the enroute stent and elected to place an additional stent to cover the dissection.
Additional Manufacturer Narrative
Updated fields: h6 - evaluation method codes; evaluation conclusion codes.
Event or Problem Description
It was reported that a dissection was identified resulting in an additional stent placement.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.During the tcar procedure, the physician advanced the 0.014" guidewire into the internal carotid artery (ica), pre-dilated, placed an enroute stent, and post-dilated successfully.Imaging was then performed, and it revealed a dissection just beyond the distal portion of the stent in the ica.The physician attributed the dissection event to either the enroute 0.014" guidewire or the enroute stent and elected to place an additional stent to cover the dissection.

• 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: 23695022
• Report Number: 2124215-2025-85688
• Device Sequence Number: 21404600
• Product Code: NIM
• UDI-Device Identifier: 00811311020430
• UDI-Public: (01)00811311020430(17)280430(10)18449324
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 02/10/2026

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-0730-CS
• Device Catalogue Number: SR-0730-CS
• Device Lot Number: 0018449324
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 02/10/2026
• Date Device Manufactured: 05/08/2025
• 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: 85 YR
• Patient Sex: Male