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

Model Number	FG11815
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Ischemia Stroke (4418)
Date of Event	05/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product lot number is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient experienced a stroke post procedure.An enroute transcarotid stent was selected for use in the right transcarotid artery revascularization (tcar) procedure.Post-procedure, prior to discharge, the patient experienced left leg deficit, and imaging revealed an ischemic stroke with anterior cerebral artery (aca) disease.The stent was patent.No intervention was performed, and the patient demonstrated improving strength with approximately 50% overall improvement.Additionally, it was reported that this patient demonstrated extensive low-density plaque, described as friable material with hounsfield unit values less than 50, including areas as low as 16.Limited visualization of the a2 segment of the right anterior cerebral artery was also noted.
Event or Problem Description
It was reported that the patient experienced a stroke post procedure.An enroute transcarotid stent was selected for use in the right transcarotid artery revascularization (tcar) procedure.Post-procedure, prior to discharge, the patient experienced left leg deficit, and imaging revealed an ischemic stroke with anterior cerebral artery (aca) disease.The stent was patent.No intervention was performed, and the patient demonstrated improving strength with approximately 50% overall improvement.Additionally, it was reported that this patient demonstrated extensive low-density plaque, described as friable material with hounsfield unit values less than 50, including areas as low as 16.Limited visualization of the a2 segment of the right anterior cerebral artery was also noted.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product lot number is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.

• 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: 25498613
• Report Number: 2124215-2026-31712
• Device Sequence Number: 10589270
• Product Code: NIM
• UDI-Device Identifier: 00811311021291
• UDI-Public: (01)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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2026

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: FG11815
• Device Catalogue Number: FG11815
• Device Lot Number: 0018422742
• 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: 05/18/2026
• Supplement Date Received by Manufacturer: 06/15/2026; 07/29/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 07/13/2026; 08/25/2026
• Date Device Manufactured: 03/01/2025
• 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: Hospitalization; Other
• Patient Age: 75 YR
• Patient Sex: Female