MAUDE Adverse Event Report: SILK ROAD MEDICAL ENROUTE TRANSCAROTID STENT; STENT, CAROTID

Model Number	SR-1040-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Confusion/ Disorientation (2553); Ischemia Stroke (4418)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced an ischemic stroke.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.Post tcar procedure, the patient woke up slowly and could not move their right upper and lower side.After a few minutes the patient was able to fully move their right leg and wiggle their toes but did not have the ability to move their right arm or hand.Imaging revealed a patent stent; however, the physician was not entirely satisfied with the stents appearance and suspected plaque prolapse.Further analysis of the imaging classified the event as a thrombotic stroke.The patient was given tpa ((tissue plasminogen activator), and no further intervention was performed.At the time of reporting, the patient's lower extremity movement had improved, but there had been no improvement in upper extremity movement.
Event or Problem Description
It was reported that the patient experienced an ischemic stroke.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.Post tcar procedure, the patient woke up slowly and could not move their right upper and lower side.After a few minutes the patient was able to fully move their right leg and wiggle their toes but did not have the ability to move their right arm or hand.Imaging revealed a patent stent; however, the physician was not entirely satisfied with the stents appearance and suspected plaque prolapse.Further analysis of the imaging classified the event as a thrombotic stroke.The patient was given tpa ((tissue plasminogen activator), and no further intervention was performed.At the time of reporting, the patient's lower extremity movement had improved, but there had been no improvement in upper extremity movement.
Additional Manufacturer Narrative
Updated fields: h6 - evaluation method codes; evaluation conclusion codes.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23598079
• Report Number: 2124215-2025-84421
• Device Sequence Number: 13335096
• Product Code: NIM
• UDI-Device Identifier: 00811311020539
• UDI-Public: (01)00811311020539(17)260630(10)18222571
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/10/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: SR-1040-CS
• Device Catalogue Number: SR-1040-CS
• Device Lot Number: 0018222571
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 02/10/2026
• Date Device Manufactured: 07/01/2023
• 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; Disability
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Race: Black Or African American