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	Numbness (2415); Obstruction/Occlusion (2422); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced stent thrombosis and stroke post procedure.An enroute transcarotid stent was selected for use in a left side transcarotid artery revascularization (tcar) procedure.During the procedure, plaque prolapse was noted within the stent and a second stent was placed to reline the vessel.The procedure was completed with no notable issues.Six days post procedure, the patient returned with right side numbness.The patient was admitted and administrated with heparin drip.Imaging performed revealed stent thrombosis and an embolic stroke.There was no p2y12 test performed but the patient was switched from plavix to brilinta and eliquis.Additionally, it was reported that the patient had an intraluminal filling defect noted prior to the tcar procedure.
Event or Problem Description
It was reported that the patient experienced stent thrombosis and stroke post procedure.An enroute transcarotid stent was selected for use in a left side transcarotid artery revascularization (tcar) procedure.During the procedure, plaque prolapse was noted within the stent and a second stent was placed to reline the vessel.The procedure was completed with no notable issues.Six days post procedure, the patient returned with right side numbness.The patient was admitted and administrated with heparin drip.Imaging performed revealed stent thrombosis and an embolic stroke.There was no p2y12 test performed but the patient was switched from plavix to brilinta and eliquis.Additionally, it was reported that the patient had an intraluminal filling defect noted prior to the tcar procedure.
Additional Manufacturer Narrative
Investigation results: device history record (dhr) review: a review of the manufacturing documentation associated with this lot was performed, and it was found that nine defective unit was rejected during the final assembly of this lot.It was confirmed that the unit was properly segregated and discarded.No manufacturing deviations were identified that could be related to the reported complaint.The review did not suggest that the adverse event experienced by the customer could be related to the manufacturing process.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a review of the enroute transcarotid stent device confirmed that the reported events are known events defined in the product's risk management documentation.These event types has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.

• 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 ; +1(763)494-1632
• MDR Report Key: 25449544
• Report Number: 2124215-2026-30820
• Device Sequence Number: 5840225
• Product Code: NIM
• UDI-Device Identifier: 00811311020478
• UDI-Public: (01)00811311020478(17)270630(10)18336967
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2026

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: 0018336967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Supplement Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 07/30/2026
• Date Device Manufactured: 07/01/2024
• 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: Other; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male