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	Stroke/CVA (1770)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced stroke-like symptoms.An enroute transcarotid neuroprotection system was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.Within two to three hours post procedure, the patient experienced stroke-like symptoms.The patient was admitted and evaluated in neurointerventional radiology, and it was reported that imaging did not reveal a stroke.The physician felt the patient did not tolerate flow reversal well.No intervention was required and the patient returned to baseline within days after the procedure.
Event or Problem Description
It was reported that the patient experienced stroke-like symptoms.An enroute transcarotid neuroprotection system was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.Within two to three hours post procedure, the patient experienced stroke-like symptoms.The patient was admitted and evaluated in neurointerventional radiology, and it was reported that imaging did not reveal a stroke.The physician felt the patient did not tolerate flow reversal well.No intervention was required and the patient returned to baseline within days after the procedure.
Additional Manufacturer Narrative
Updated fields: h6 - evaluation method codes; evaluation conclusion codes.It was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.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 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: 24706026
• Report Number: 2124215-2026-16740
• Device Sequence Number: 10462966
• Product Code: NTE
• UDI-Device Identifier: 00811311021062
• UDI-Public: (01)00811311021062(11)250827(10)307066
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/18/2026

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: 0000307066
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 05/18/2026
• Date Device Manufactured: 08/27/2025
• 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: Other
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Race: White