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 Codes	Stroke/CVA (1770); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	01/08/2026
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 left side transcarotid artery revascularization (tcar) procedure.The procedure was completed with no notable issues.The patient was on plavix for two months and imaging showed a patent stent.One year after the tcar procedure, the patient presented with symptoms and was admitted.Imaging revealed stent thrombosis and occlusion.Further imaging review revealed that there was low-density material inside the stent that was consistent with neointimal hyperplasia (nih).The stent was explanted, and the carotid was patched.The physician noted substantial inflammation of the perivascular tissues at the time of device explant, which can be seen in patients with a nickel allergy, though this allergy was not confirmed.Additionally, it was reported that the patient had a transient ischemic attack (tia), but the resolution of symptoms was not confirmed.
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 left side transcarotid artery revascularization (tcar) procedure.The procedure was completed with no notable issues.The patient was on plavix for two months and imaging showed a patent stent.One year after the tcar procedure, the patient presented with symptoms and was admitted.Imaging revealed stent thrombosis and occlusion.Further imaging review revealed that there was low-density material inside the stent that was consistent with neointimal hyperplasia (nih).The stent was explanted, and the carotid was patched.The physician noted substantial inflammation of the perivascular tissues at the time of device explant, which can be seen in patients with a nickel allergy, though this allergy was not confirmed.Additionally, it was reported that the patient had a transient ischemic attack (tia), but the resolution of symptoms was not confirmed.
Additional Manufacturer Narrative
Investigation results: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.A risk review performed for the enroute transcarotid stent device confirmed that the reported events are known events defined in the product risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint the most probable cause for this complaint was considered known inherent risk of device.

• 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: 24262113
• Report Number: 2124215-2026-06501
• Device Sequence Number: 15846693
• Product Code: NIM
• UDI-Device Identifier: 00811311020478
• UDI-Public: (01)00811311020478(17)270228(10)18292389
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 03/31/2026

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-0840-CS
• Device Catalogue Number: SR-0840-CS
• Device Lot Number: 0018292389
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/31/2026
• Date Device Manufactured: 03/01/2024
• 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: 78 YR
• Patient Sex: Male