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 Code	Convulsion/Seizure (4406)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a seizure.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.During the tcar procedure, the patient had a seizure while on clamp.The physician did not believe the seizure was due to intolerance but rather considered it part of the reperfusion spectrum.The patient made a full recovery, and no intervention was required as the event was self-limiting.
Additional Manufacturer Narrative
Updated fields: h6 - evaluation method codes; evaluation conclusion codes.
Event or Problem Description
It was reported that the patient experienced a seizure.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.During the tcar procedure, the patient had a seizure while on clamp.The physician did not believe the seizure was due to intolerance but rather considered it part of the reperfusion spectrum.The patient made a full recovery, and no intervention was required as the event was self-limiting.

• 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: 23032027
• Report Number: 2124215-2025-63017
• Device Sequence Number: 15748412
• Product Code: NIM
• UDI-Device Identifier: 00811311021277
• UDI-Public: (01)00811311021277(17)280131(10)18421331
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 12/01/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: FG11815
• Device Catalogue Number: FG11815
• Device Lot Number: 0018421331
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 12/01/2025
• Date Device Manufactured: 02/25/2025
• 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: Other
• Patient Age: 62 YR
• Patient Sex: Male