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	Eye Injury (1845); Fatigue (1849); Hemorrhagic Stroke (4417)
Date of Event	07/30/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient experienced a brain hemorrhage, which ultimately resulted in death.An enroute transcarotid stent was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.Post tcar procedure, the patient had a dilated right eye pupil and was lethargic.Imaging revealed a brain hemorrhage.No additional surgical intervention was performed.The patient was placed on comfort care and ultimately passed away.
Event or Problem Description
It was reported that the patient experienced a brain hemorrhage, which ultimately resulted in death.An enroute transcarotid stent was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.Post tcar procedure, the patient had a dilated right eye pupil and was lethargic.Imaging revealed a brain hemorrhage.No additional surgical intervention was performed.The patient was placed on comfort care and ultimately passed away.
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: 22913303
• Report Number: 2124215-2025-59928
• Device Sequence Number: 13078117
• Product Code: NIM
• UDI-Device Identifier: 00811311021284
• UDI-Public: (01)00811311021284(17)270430(10)18322744
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/16/2025

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: 0018322744
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/16/2025
• Date Device Manufactured: 05/27/2024
• 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: Death; Other
• Patient Age: 66 YR
• Patient Sex: Male