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	Paralysis (1997); Ischemia Stroke (4418); Embolism/Embolus (4438)
Date of Event	10/31/2025
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.During the procedure, plaque was identified within the stent.The physician elected to post dilate the area with plaque and completed the procedure.Post tcar procedure, the patient passed the neurological check but experienced an embolic stroke five hours later.Imaging revealed that the patient had frontal emboli and a small atheroma area located within the stent, but the stent was widely patent.Additional information provided indicated that the patient was not dual antiplatelet therapy (dapt) complaint as aspirin was not administered.However, based on the p2y12 inhibitor test results, the patient was responsive.The patient symptoms resolved completely within 48 hours of the tcar procedure.
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.During the procedure, plaque was identified within the stent.The physician elected to post dilate the area with plaque and completed the procedure.Post tcar procedure, the patient passed the neurological check but experienced an embolic stroke five hours later.Imaging revealed that the patient had frontal emboli and a small atheroma area located within the stent, but the stent was widely patent.Additional information provided indicated that the patient was not dual antiplatelet therapy (dapt) complaint as aspirin was not administered.However, based on the p2y12 inhibitor test results, the patient was responsive.The patient symptoms resolved completely within 48 hours of the tcar procedure.
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: 23694935
• Report Number: 2124215-2025-85716
• Device Sequence Number: 15734265
• Product Code: NIM
• UDI-Device Identifier: 00811311021291
• UDI-Public: (01)00811311021291(17)280331(10)18442900
• 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): 01/27/2026

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 Model Number: FG11815
• Device Catalogue Number: FG11815
• Device Lot Number: 0018442900
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/27/2026
• Date Device Manufactured: 04/22/2025
• 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: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Race: White