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

Model Number	FG11815
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent delivery system (sds) was unable to be removed, resulting in additional intervention.An enroute transcarotid stent was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.The stent was successfully deployed however; the physician was unable to remove the sds.The physician attempted to recapture the sds, attempted to manipulate the neck, and attempted to advance a buddy wire to remove the sds, but troubleshooting attempts were unsuccessful.The physician converted the procedure to a carotid endarterectomy (cea) and surgically explanted the stent.A portion of the artery was removed and bypassed, and the patient was admitted to the hospital beyond the standard of care as a result of the event.
Additional Manufacturer Narrative
Updated fields: b5 - describe event or problem.H6 - evaluation method codes; evaluation conclusion codes.
Event or Problem Description
It was reported that the stent delivery system (sds) was unable to be removed, resulting in additional intervention.An enroute transcarotid stent was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.The stent was successfully deployed however; the physician was unable to remove the sds.The physician attempted to recapture the sds, attempted to manipulate the neck, and attempted to advance a buddy wire to remove the sds, but troubleshooting attempts were unsuccessful.The physician converted the procedure to a carotid endarterectomy (cea) and surgically explanted the stent.A portion of the artery was removed and bypassed, and the patient was admitted to the hospital beyond the standard of care as a result of the event.It was further reported that the portion of the common carotid and internal carotid artery were removed due to damage and existing disease.The physician elected to repair the artery with a tubular graft.

• 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: 23360585
• Report Number: 2124215-2025-75156
• Device Sequence Number: 8964583
• Product Code: NIM
• UDI-Device Identifier: 00811311021314
• UDI-Public: (01)00811311021314(17)280229(10)18432167
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 12/04/2025

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: 0018432167
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/04/2025
• Date Device Manufactured: 03/25/2025
• 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: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female