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

Model Number	SR-0830-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Ischemia Stroke (4418); Facial Paralysis (4585)
Date of Event	04/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced an embolic stroke.An enroute transcarotid stent was selected for use.The patient underwent a left sided transcarotid artery revascularization (tcar) procedure with no notable issues.The following day, greater than 24 hours following the tcar procedure, follow up with a healthcare professional revealed the patient was experiencing a stroke, with notable facial droop and right sided weakness.The patient was admitted to the hospital beyond the standard of care for monitoring.No additional intervention was performed.At the time of reporting, the symptoms had not resolved.
Additional Manufacturer Narrative
No further information regarding patient status was available, despite request by bsc.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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21963624
• Report Number: 2124215-2025-28190
• Device Sequence Number: 7265388
• Product Code: NIM
• UDI-Device Identifier: 00811311020461
• UDI-Public: (01)00811311020461(17)260731(10)18229129
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 05/05/2025

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: 07/31/2026
• Device Model Number: SR-0830-CS
• Device Catalogue Number: SR-0830-CS
• Device Lot Number: 0018229129
• 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: 04/07/2025
• Initial Report FDA Received Date: 05/05/2025
• Date Device Manufactured: 08/01/2023
• 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: Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 80 KG