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

Model Number	FG11815
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Stent failure / patient need to return to surgery, and left explant of internal carotid artery stent, carotid artery endarterectomy with bovine pericardial patch angioplasty.

• Brand Name: ENROUTE TRANSCAROTID STENT
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): SILK ROAD MEDICAL, INC.; 1213 innsbruck drive; sunnyvale CA 94089
• MDR Report Key: 21282438
• Report Number: 21282438
• Device Sequence Number: 20823621
• Product Code: NIM
• UDI-Device Identifier: 00811311021291
• UDI-Public: (01)00811311021291
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/28/2025
• Report Date (Section F): 01/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG11815
• Device Catalogue Number: SR-090740-TCS
• Device Lot Number: 18308170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Date Report Sent to FDA: 01/28/2025