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	Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a stroke, requiring additional intervention.An enroute transcarotid stent was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.The procedure was completed without issue, and the patient passed the post procedure neuro check.Approximately eighteen hours post procedure, the patient experienced a stroke, and thrombosis was identified within the stent.Interventional radiology (ir) took the patient back to surgery to address the stent thrombosis.After an unknown series of events, the patient underwent a craniotomy, and remained hospitalized at the time of reporting.The reason for the craniotomy was not reported to boston scientific.
Event or Problem Description
It was reported that the patient experienced a stroke, requiring additional intervention.An enroute transcarotid stent was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.The procedure was completed without issue, and the patient passed the post procedure neuro check.Approximately eighteen hours post procedure, the patient experienced a stroke, and thrombosis was identified within the stent.Interventional radiology (ir) took the patient back to surgery to address the stent thrombosis.After an unknown series of events, the patient underwent a craniotomy, and remained hospitalized at the time of reporting.The reason for the craniotomy was not reported to boston scientific.
Additional Manufacturer Narrative
Updated fields: h6 - evaluation method codes; evaluation conclusion codes.

• 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: 23998101
• Report Number: 2124215-2026-01131
• Device Sequence Number: 18772384
• Product Code: NIM
• UDI-Device Identifier: 00811311020539
• UDI-Public: (01)00811311020539(17)271031(10)18385818
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 02/19/2026

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: 0018385818
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/19/2026
• Date Device Manufactured: 11/02/2024
• 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: 60 YR
• Patient Sex: Male