MAUDE Adverse Event Report: Silk Road Medical ENROUTE Transcarotid Stent; Stent, Carotid

Model Number	FG11815
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Codes	Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Blurred Vision (2137); Obstruction/Occlusion (2422); Speech Disorder (4415); Thrombosis/Thrombus (4440); Facial Paralysis (4585)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a stroke.An enroute transcarotid stent was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.It was noted that the patient's internal carotid artery (ica) had a heavy calcium burden and the physician elected to use a non-bsc device to predilate the vessel.After the stent was placed, the physician decided it looked good in the angiogram and elected to not post dilate.Four hours post tcar procedure, the patient experienced hypotension and a stroke with right eye vision changes, left facial droop, and speech issues.Additionally, the computed tomography angiography (cta) showed significant calcific burden impacting the vessel and stent, with evidence that the stent was compressed and subsequently thrombosed, resulting in full occlusion.The ica appeared severely compromised with minimal flow at the skull base.The patient was flown to a different hospital and the stent was explanted.The patient's symptoms resolved within 24 hours after the stent was explanted.
Event or Problem Description
It was reported that the patient experienced a stroke.An enroute transcarotid stent was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.It was noted that the patient's internal carotid artery (ica) had a heavy calcium burden and the physician elected to use a non-bsc device to predilate the vessel.After the stent was placed, the physician decided it looked good in the angiogram and elected to not post dilate.Four hours post tcar procedure, the patient experienced hypotension and a stroke with right eye vision changes, left facial droop, and speech issues.Additionally, the computed tomography angiography (cta) showed significant calcific burden impacting the vessel and stent, with evidence that the stent was compressed and subsequently thrombosed, resulting in full occlusion.The ica appeared severely compromised with minimal flow at the skull base.The patient was flown to a different hospital and the stent was explanted.The patient's symptoms resolved within 24 hours after the stent was explanted.
Additional Manufacturer Narrative
The device history record review confirmed that the device met all material, assembly, and performance specifications prior to distribution.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.A review of the enroute transcarotid stent device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to patient condition.

• 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): CORDIS US CORP; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25786571
• Report Number: 2124215-2026-37233
• Device Sequence Number: 21513292
• Product Code: NIM
• UDI-Device Identifier: 00811311021291
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG11815
• Device Catalogue Number: FG11815
• Device Lot Number: 0018527707
• 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: 06/15/2026
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 11/15/2025
• 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; Other
• Patient Age: 76 YR
• Patient Sex: Female