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	Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a thrombotic stroke requiring additional intervention.An enroute transcarotid stent was selected for use in the left sided transcarotid artery revascularization (tcar) procedure.The patient presented as asymptomatic.Final angiograms were taken in orthogonal views, and the stent was observed to be patent.The patient woke up neurologically intact.A few hours post t-car, the physician reported the patient had stroke-like symptoms.A cta of the head and neck was performed, which revealed the stent thrombosed near the bifurcation.The patient was started on integrilin and had a thrombectomy followed by placement of a wallstent.The procedure was successful, and the stent was patent.The stroke symptoms were reported to have resolved the following day.

• 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: 22096001
• Report Number: 2124215-2025-34290
• Device Sequence Number: 18157566
• Product Code: NIM
• UDI-Device Identifier: 00811311021314
• UDI-Public: (01)00811311021314(17)280131(10)18414165
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/28/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: FG11815
• Device Catalogue Number: FG11815
• Device Lot Number: 0018414165
• 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: 04/29/2025
• Initial Report FDA Received Date: 05/28/2025
• Date Device Manufactured: 02/04/2025
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female