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

Model Number	SR-0940-CS
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Vascular Dissection (3160)
Date of Event	05/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that no flow was observed following stent deployment.The patient presented as asymptomatic for a right transcarotid revascularization (tcar) procedure.An enroute transcarotid stent (tss) system was selected for use.Following stent deployment at the lesion site, imaging demonstrated contrast inflow into the stent with no distal outflow beyond the stent.An additional enroute stent was placed, followed by deployment of a third enroute stent; however, subsequent imaging continued to demonstrate absence of distal flow.A cutdown with stent explantation was performed by the physician; however, the number of stents removed could not be confirmed.The physician subsequently proceeded with carotid endarterectomy (cea).Imaging continued to demonstrate lack of flow to the brain.The patient required hospitalization beyond the standard of care.The patient outcome was reported as expected to fully recover.Upon review of the pre-procedure computed tomography (ct) angiography, there was concern that the treated lesion may have represented long-segment disease.It was further reported that it was unclear whether the stents were deployed within the true lumen or false lumen.

• 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: 25365595
• Report Number: 2124215-2026-29467
• Device Sequence Number: 10650635
• Product Code: NIM
• UDI-Device Identifier: 00811311020508
• UDI-Public: (01)00811311020508(17)270331(10)18309214
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 07/31/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SR-0940-CS
• Device Catalogue Number: SR-0940-CS
• Device Lot Number: 0018309214
• 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: 05/06/2026
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 07/31/2026
• Date Device Manufactured: 04/01/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male