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

Model Number	SR-0940-CS
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced an embolic stroke, requiring additional surgical intervention.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.After completion of the procedure, the patient experienced neurological deficit.Imaging performed revealed an embolic stroke in the left hemisphere and the physician noted that the proximal end of the second stent was placed in a dissection plane in the common carotid artery (cca).The physician performed a cea to explant the stents and patched the carotid artery.
Additional Manufacturer Narrative
A secondary mdr was reported under 2124215-2025-82875 as there are two products associated with the same event/patient.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23582708
• Report Number: 2124215-2025-82852
• Device Sequence Number: 9305510
• Product Code: NIM
• UDI-Device Identifier: 00811311020508
• UDI-Public: (01)00811311020508(17)271130(10)18399741
• 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
• Device Explanted 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
• Report Date (Section B): 11/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SR-0940-CS
• Device Catalogue Number: SR-0940-CS
• Device Lot Number: 0018399741
• 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: 10/22/2025
• Initial Report FDA Received Date: 11/18/2025
• Date Device Manufactured: 12/13/2024
• 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 Age: 87 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Race: White