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

Model Number	SR-0840-CS
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Ischemia Stroke (4418); Embolism/Embolus (4438)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product or patient information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient experienced a stroke.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.During the tcar procedure, the physician had inadvertently placed the stent in a dissection plane that was caused by a non-boston scientific wire.Six hours post procedure, the patient experienced an embolic stroke.Post procedure imaging revealed that the left ophthalmic artery was occluded.No further information was provided to boston scientific.
Event or Problem Description
It was reported that the patient experienced a stroke.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.During the tcar procedure, the physician had inadvertently placed the stent in a dissection plane that was caused by a non-boston scientific wire.Six hours post procedure, the patient experienced an embolic stroke.Post procedure imaging revealed that the left ophthalmic artery was occluded.No further information was provided to boston scientific.It was further reported that no intervention was performed.
Additional Manufacturer Narrative
Updated fields: a3a - sex a3b - gender b5- describe event or problem h6 - evaluation method codes; evaluation conclusion codes.Detailed product or patient information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient experienced a stroke.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.During the tcar procedure, the physician had inadvertently placed the stent in a dissection plane that was caused by a non-boston scientific wire.Six hours post procedure, the patient experienced an embolic stroke.Post procedure imaging revealed that the left ophthalmic artery was occluded.No further information was provided to boston scientific.It was further reported that no intervention was performed.
Additional Manufacturer Narrative
Detailed product or patient information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.

• 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: 23372793
• Report Number: 2124215-2025-75229
• Device Sequence Number: 13249510
• Product Code: NIM
• UDI-Device Identifier: 00811311020478
• UDI-Public: (01)00811311020478
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 02/19/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SR-0840-CS
• Device Catalogue Number: SR-0840-CS
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 11/18/2025; 01/28/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/12/2025; 02/19/2026
• 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 Sex: Male