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

Model Number	FG11815
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Stroke/CVA (1770); Vascular Dissection (3160)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced a stroke.An enroute transcarotid stent was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.The next morning that the patient had stroke-like symptoms.The patient was taken for a computed tomography (ct) scan which showed that the stent was compressed proximally and appeared to be placed in a dissection plane.The patient was taken back to the operating room, and a carotid endarterectomy (cea) was performed where the stent was explanted.The patient was reported to have been admitted to the hospital beyond the standard of care.At the time of reporting, the patient was discharged to a rehabilitation facility and was expected to fully recover.
Event or Problem Description
It was reported that patient experienced a stroke.An enroute transcarotid stent was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.The next morning that the patient had stroke-like symptoms.The patient was taken for a computed tomography (ct) scan which showed that the stent was compressed proximally and appeared to be placed in a dissection plane.The patient was taken back to the operating room, and a carotid endarterectomy (cea) was performed where the stent was explanted.The patient was reported to have been admitted to the hospital beyond the standard of care.At the time of reporting, the patient was discharged to a rehabilitation facility and was expected to fully recover.
Additional Manufacturer Narrative
Investigation results: device history record (dhr) review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a review of the enroute transcarotid stent device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unintended use error caused or contributed to event.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 25140177
• Report Number: 2124215-2026-25418
• Device Sequence Number: 15781860
• Product Code: NIM
• UDI-Device Identifier: 00811311021260
• UDI-Public: (01)00811311021260(17)280229(10)18428638
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 07/15/2026

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: 0018428638
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 07/15/2026
• Date Device Manufactured: 03/15/2025
• 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: 72 YR
• Patient Sex: Unknown