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

Model Number	SR-0840-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a dissection occurred, which was treated using an additional stent.An enroute transcarotid stent was selected for use in the left sided transcarotid artery revascularization (tcar) procedure.The 8mm x 40mm was advanced, and then a tcar timeout was performed to take some images.The surgeon suspected there was a small dissection, and elected to place an additional enroute stent, 7mm x 30mm, distally to the 8mm x 40mm, overlapping.Further imaging was reviewed, and the surgeon was satisfied with the stent placement.The tcar procedure was completed, and there were no further patient complications as a result of the dissection.
Event or Problem Description
It was reported that a dissection occurred, which was treated using an additional stent.An enroute transcarotid stent was selected for use in the left sided transcarotid artery revascularization (tcar) procedure.The 8mm x 40mm was advanced, and then a tcar timeout was performed to take some images.The surgeon suspected there was a small dissection, and elected to place an additional enroute stent, 7mm x 30mm, distally to the 8mm x 40mm, overlapping.Further imaging was reviewed, and the surgeon was satisfied with the stent placement.The tcar procedure was completed, and there were no further patient complications as a result of the dissection.
Additional Manufacturer Narrative
Updated fields: h6 - evaluation method codes, evaluation conclusion codes.
Additional Manufacturer Narrative
Updated fields: e1 - initial reporter email.
Event or Problem Description
It was reported that a dissection occurred, which was treated using an additional stent.An enroute transcarotid stent was selected for use in the left sided transcarotid artery revascularization (tcar) procedure.The 8mm x 40mm was advanced, and then a tcar timeout was performed to take some images.The surgeon suspected there was a small dissection, and elected to place an additional enroute stent, 7mm x 30mm, distally to the 8mm x 40mm, overlapping.Further imaging was reviewed, and the surgeon was satisfied with the stent placement.The tcar procedure was completed, and there were no further patient complications as a result of 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: 22290505
• Report Number: 2124215-2025-40306
• Device Sequence Number: 8929287
• Product Code: NIM
• UDI-Device Identifier: 00811311020478
• UDI-Public: (01)00811311020478(17)260731(10)18229131
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 12/03/2025

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 Expiration Date: 07/31/2026
• Device Model Number: SR-0840-CS
• Device Catalogue Number: SR-0840-CS
• Device Lot Number: 0018229131
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 11/04/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/18/2025; 12/03/2025
• Date Device Manufactured: 08/01/2023
• 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: 86 YR
• Patient Sex: Male
• Patient Race: White