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

Model Number	SR-0940-CS
Medical Device Problem Codes	Nonstandard Device (1420); Defective Device (2588)
Health Effect - Clinical Codes	Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent was compressed, and the patient experienced a stroke.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.The target vessel was significantly calcified.During the tcar procedure, there was inadequate imaging and post-dilation as a result of patient agitation.Approximately 45 minutes post procedure, the patient experienced an ischemic stroke and imaging identified calcium compressing the stent.Neurology interventional radiologists performed a thrombectomy and successfully post-dilated the stent.No further information was provided to boston scientific.
Event or Problem Description
It was reported that the stent was compressed, and the patient experienced a stroke.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.The target vessel was significantly calcified.During the tcar procedure, there was inadequate imaging and post-dilation as a result of patient agitation.Approximately 45 minutes post procedure, the patient experienced an ischemic stroke and imaging identified calcium compressing the stent.Neurology interventional radiologists performed a thrombectomy and successfully post-dilated the stent.No further information was provided to boston scientific.

• 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: 23336154
• Report Number: 2124215-2025-74028
• Device Sequence Number: 18506953
• Product Code: NIM
• UDI-Device Identifier: 00811311020508
• UDI-Public: (01)00811311020508(17)270731(10)18352047
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/27/2026

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: SR-0940-CS
• Device Catalogue Number: SR-0940-CS
• Device Lot Number: 0018352047
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 02/27/2026
• Date Device Manufactured: 08/05/2024
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female