MAUDE Adverse Event Report: Silk Road Medical ENROUTE Transcarotid Neuroprotection System; Embolic protection filtering guidewire

Model Number	FG12531
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a dissection was identified requiring additional intervention.An enroute transcarotid neuroprotection system was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.During the procedure, a dissection was identified after arterial sheath placement.The physician was unable to advance the interventional wire through the dissection and elected to convert the procedure to a carotid endarterectomy (cea).
Event or Problem Description
It was reported that a dissection was identified requiring additional intervention.An enroute transcarotid neuroprotection system was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.During the procedure, a dissection was identified after arterial sheath placement.The physician was unable to advance the interventional wire through the dissection and elected to convert the procedure to a carotid endarterectomy (cea).
Additional Manufacturer Narrative
The device history record review confirmed that the device met all material, assembly, and performance specifications prior to distribution.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 review of the enroute transcarotid neuroprotection system 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.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.

• Brand Name: ENROUTE Transcarotid Neuroprotection System
• Common Device Name: Embolic protection filtering guidewire
• Manufacturer (Section D): Silk Road Medical; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): Boston Scientific Corporation; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 50166918
• Report Number: 2124215-2026-42302
• Device Sequence Number: 21342081
• Product Code: NTE
• UDI-Device Identifier: 00811311021062
• UDI-Public: (01)00811311021062(11)260424(10)39175461
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: FG12531
• Device Catalogue Number: FG12531
• Device Lot Number: 0039175461
• 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: 07/14/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 04/24/2026
• 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: Required Intervention
• Patient Sex: Unknown