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

Model Number	FG11815
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Thrombosis/Thrombus (4440)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one day after the procedure, there was some stent compression due to calcium and thrombus was identified within the stent.An enroute transcarotid stent was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.Prior to the tcar procedure, it was identified that the patient's anatomy had pinch point calcium.Despite this, the tcar procedure went well.Post procedure, the patient's systolic pressures were lower, around 100 mm hg, and imaging revealed thrombus within the stent.Additionally, there was some stent compression identified due to calcium with no report of occlusion or inflow/outflow issues.The physician elected to switch the patient to brilinta and continue with medical management.No further patient complications were reported.
Event or Problem Description
It was reported that one day after the procedure, there was some stent compression due to calcium and thrombus was identified within the stent.An enroute transcarotid stent was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.Prior to the tcar procedure, it was identified that the patient's anatomy had pinch point calcium.Despite this, the tcar procedure went well.Post procedure, the patient's systolic pressures were lower, around 100 mm hg, and imaging revealed thrombus within the stent.Additionally, there was some stent compression identified due to calcium with no report of occlusion or inflow/outflow issues.The physician elected to switch the patient to brilinta and continue with medical management.No further patient complications were reported.
Additional Manufacturer Narrative
Updated fields: h6 - evaluation method codes; evaluation conclusion codes.

• 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: 23547381
• Report Number: 2124215-2025-80956
• Device Sequence Number: 9775637
• Product Code: NIM
• UDI-Device Identifier: 00811311021284
• UDI-Public: (01)00811311021284(17)270531(10)18328416
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/02/2025

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: FG11815
• Device Catalogue Number: FG11815
• Device Lot Number: 0018328416
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/02/2025
• Date Device Manufactured: 06/07/2024
• 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: Other; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female