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); Ischemia Stroke (4418)
Date of Event	03/18/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
B2-date of death: the patient passed away at a rehabilitation center a few weeks ago.Therefore, the patient's date of death was approximated to (b)(6) 2026 based on the limited information provided.
Event or Problem Description
It was reported that the patient experienced a stroke.An enroute transcarotid neuroprotection system was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.During the post procedure neurological check, the patient displayed movement in all four extremities however, they were not equal.The patient's left extremities showed weakness.Imaging revealed a new embolic stroke and the stent appeared patent.No intervention was performed and the patient was discharged to a rehabilitation center.Additionally, it was reported that the patient passed away while at the rehabilitation center.The official cause of death was not provided, and no further information was provided to boston scientific.
Additional Manufacturer Narrative
B2-date of death: the patient passed away at a rehabilitation center a few weeks ago.Therefore, the patient's date of death was approximated to (b)(6) 2026 based on the limited information provided.Updated fields: b7- other relevant history; 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.
Additional Manufacturer Narrative
This report is being submitted to correct the type of reportable event field (h1).B2-date of death: the patient passed away at a rehabilitation center a few weeks ago.Therefore, the patient's date of death was approximated to (b)(6) 2026 based on the limited information provided.Updated fields: b7- other relevant history; 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.
Event or Problem Description
It was reported that the patient experienced a stroke.An enroute transcarotid neuroprotection system was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.During the post procedure neurological check, the patient displayed movement in all four extremities however, they were not equal.The patient's left extremities showed weakness.Imaging revealed a new embolic stroke and the stent appeared patent.No intervention was performed and the patient was discharged to a rehabilitation center.Additionally, it was reported that the patient passed away while at the rehabilitation center.The official cause of death was not provided, and no further information was provided to boston scientific.
Event or Problem Description
It was reported that the patient experienced a stroke.An enroute transcarotid neuroprotection system was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.During the post procedure neurological check, the patient displayed movement in all four extremities however, they were not equal.The patient's left extremities showed weakness.Imaging revealed a new embolic stroke and the stent appeared patent.No intervention was performed and the patient was discharged to a rehabilitation center.Additionally, it was reported that the patient passed away while at the rehabilitation center.The official cause of death was not provided, and no further information was provided to boston scientific.

• 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 ; +1(612)875-7234
• MDR Report Key: 25236663
• Report Number: 2124215-2026-27342
• Device Sequence Number: 5108983
• Product Code: NTE
• UDI-Device Identifier: 00811311021062
• UDI-Public: (01)00811311021062(11)250714(10)306963
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 09/10/2026

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: 0000306963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Supplement Date Received by Manufacturer: 05/28/2026; 08/18/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 06/25/2026; 09/10/2026
• Date Device Manufactured: 07/14/2025
• 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: Death; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Unknown