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

Model Number	SR-0940-CS
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent was deployed in a dissection plane, which required additional intervention and device explantation.The patient presented as symptomatic with severe tortuosity in the distal right internal carotid artery (ica) for a transcarotid artery revascularization (tcar) procedure.An enroute transcarotid stent system (tss) was selected for use.During the procedure, imaging revealed that the stent was deployed in a dissection plane.The physician converted to a carotid endarterectomy (cea) and surgically explanted the stent.A successful cea was performed, and the patient was neurologically intact post-procedure.
Additional Manufacturer Narrative
Investigation results: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.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.A risk review was completed and confirmed that the event does not represent a new or unanticipated risk.This event type was accounted for during the product risk analysis to support an acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of "unable to exclude device problem".
Event or Problem Description
It was reported that the stent was deployed in a dissection plane, which required additional intervention and device explantation.The patient presented as symptomatic with severe tortuosity in the distal right internal carotid artery (ica) for a transcarotid artery revascularization (tcar) procedure.An enroute transcarotid stent system (tss) was selected for use.During the procedure, imaging revealed that the stent was deployed in a dissection plane.The physician converted to a carotid endarterectomy (cea) and surgically explanted the stent.A successful cea was performed, and the patient was neurologically intact post-procedure.

• 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: 24205657
• Report Number: 2124215-2026-05182
• Device Sequence Number: 9855536
• Product Code: NIM
• UDI-Device Identifier: 00811311020508
• UDI-Public: (01)00811311020508(17)270930(10)18377898
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/30/2026

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-0940-CS
• Device Catalogue Number: SR-0940-CS
• Device Lot Number: 0018377898
• 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: 01/02/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 10/14/2024
• 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: 82 YR
• Patient Sex: Male
• Patient Race: White