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 Codes	Muscle Weakness/Atrophy (1967); Speech Disorder (4415); Ischemia Stroke (4418)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced an ischemic stroke.The patient presented as asymptomatic for a left transcarotid revascularization (tcar) procedure.An enroute transcarotid neuroprotection system (nps) was selected for use.During the procedure, neuromonitoring demonstrated signs of change prior to clamping, after which the physician proceeded with clamping and completed the intervention.Stroke symptoms appeared immediately postoperatively on the right side and included speech involvement as well as right arm and right leg deficits.Imaging confirmed an ischemic stroke.All symptoms resolved within one hour except for persistent arm weakness.
Event or Problem Description
It was reported that the patient experienced an ischemic stroke.The patient presented as asymptomatic for a left transcarotid revascularization (tcar) procedure.An enroute transcarotid neuroprotection system (nps) was selected for use.During the procedure, neuromonitoring demonstrated signs of change prior to clamping, after which the physician proceeded with clamping and completed the intervention.Stroke symptoms appeared immediately postoperatively on the right side and included speech involvement as well as right arm and right leg deficits.Imaging confirmed an ischemic stroke.All symptoms resolved within one hour except for persistent arm weakness.
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 of the enroute tc neuroprotection system plus was completed and confirmed that the events of ischemic stroke, muscle weakness, and speech disorders do not represent new or unanticipated risks.These event types were 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 "known inherent risk of device".

• 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): 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: 24513777
• Report Number: 2124215-2026-12068
• Device Sequence Number: 18578392
• Product Code: NTE
• UDI-Device Identifier: 00811311021062
• UDI-Public: (01)00811311021062(11)250602(10)306896
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/10/2026

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: 0000306896
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/10/2026
• Date Device Manufactured: 06/02/2025
• 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: Disability
• Patient Age: 70 YR
• Patient Sex: Male