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	Dysphasia (2195); Numbness (2415); Obstruction/Occlusion (2422); Ischemia Stroke (4418); Embolism/Embolus (4438)
Date of Event	08/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced an ipsilateral embolic stroke four days after the procedure.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.The procedure was completed with no notable issues.Of note, plaque prolapse was not recognized at the time of the procedure.Four days after tcar procedure, the patient presented with stroke symptoms (right hand numbness and facial aphasia).The patient was treated with tnk (tenecteplase).The following day the patient experienced aphasia, and the symptoms had not resolved at the time of reporting.Imaging performed reveled intraluminal material.A p2y12 resistance test was performed post procedure, and the patient was responsive to p2y12 platelet function test with a platelet reactivity unit (pru) of 123.
Event or Problem Description
It was reported that the patient experienced an ipsilateral embolic stroke four days after the procedure.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.The procedure was completed with no notable issues.Of note, plaque prolapse was not recognized at the time of the procedure.Four days after tcar procedure, the patient presented with stroke symptoms (right hand numbness and facial aphasia).The patient was treated with tnk (tenecteplase).The following day the patient experienced aphasia, and the symptoms had not resolved at the time of reporting.Imaging performed reveled intraluminal material.A p2y12 resistance test was performed post procedure, and the patient was responsive to p2y12 platelet function test with a platelet reactivity unit (pru) of 123.
Additional Manufacturer Narrative
H6: patient code was updated based on internal review and conclusion code was updated based on additional information.

• 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: 22956407
• Report Number: 2124215-2025-60670
• Device Sequence Number: 20945781
• Product Code: NIM
• UDI-Device Identifier: 00811311021291
• UDI-Public: (01)00811311021291(17)270831(10)18370531
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/14/2026

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: 0018370531
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 01/14/2026
• Date Device Manufactured: 09/20/2024
• 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
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Race: White