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

Model Number	FG11815
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	12/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a watershed stroke.An enroute transcarotid stent was selected for use in a left side transcarotid artery revascularization (tcar) procedure.During the procedure, after stent placement, the neuromonitoring noted intolerance flow reversal, the physician switched to low flow and ultimately unclamped for one minute.The physician re-clamped and completed the procedure and the patient was back to baseline.The next day, eighteen hours post procedure, the patient experienced right leg weakness upon ambulation.Imaging performed revealed patent stent but confirmed watershed infarcts.The patient will be going to rehabilitation with a good prognosis for full recovery.
Additional Manufacturer Narrative
Investigation results: the device was not returned for analysis, as it is still implanted.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 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 risk review performed for the enroute transcarotid stent device confirmed that the events of ischemia stroke and muscle weakness are known events defined in the product risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint the most probable cause for this complaint was considered known inherent risk of device.
Event or Problem Description
It was reported that the patient experienced a watershed stroke.An enroute transcarotid stent was selected for use in a left side transcarotid artery revascularization (tcar) procedure.During the procedure, after stent placement, the neuromonitoring noted intolerance flow reversal, the physician switched to low flow and ultimately unclamped for one minute.The physician re-clamped and completed the procedure and the patient was back to baseline.The next day, eighteen hours post procedure, the patient experienced right leg weakness upon ambulation.Imaging performed revealed patent stent but confirmed watershed infarcts.The patient will be going to rehabilitation with a good prognosis for full recovery.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24222047
• Report Number: 2124215-2026-05490
• Device Sequence Number: 9365965
• Product Code: NIM
• UDI-Device Identifier: 00811311021314
• UDI-Public: (01)00811311021314(17)280531(10)18466819
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: FG11815
• Device Catalogue Number: FG11815
• Device Lot Number: 0018466819
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 06/23/2025
• 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: 74 YR
• Patient Sex: Male
• Patient Race: White