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

Model Number	SR-0840-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Transient Ischemic Attack (2109); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced in-stent thrombosis, leading to device explant.The patient presented with symptoms.An enroute transcarotid stent system was selected for a right transcarotid artery revascularization (tcar) procedure.Approximately 26 hours post-procedure, the patient experienced a tia, with symptoms manifesting on the left side.Computed tomography angiography (cta) revealed a filling defect, indicating the presence of thrombus and plaque prolapse material within the stent lumen.Although the patient had passed the post-procedure neurological check, postoperative blood pressure exceeded 230 mmhg.Compliance with dual antiplatelet therapy (dapt) was confirmed; however, no p2y12 inhibitor test had been performed.The stent was subsequently explanted.Images of the explanted stent demonstrated plaque prolapse and platelet aggregates within the stent.The patient was reportedly doing well.
Event or Problem Description
It was reported that the patient experienced in-stent thrombosis, leading to device explant.The patient presented with symptoms.An enroute transcarotid stent system was selected for a right transcarotid artery revascularization (tcar) procedure.Approximately 26 hours post-procedure, the patient experienced a tia, with symptoms manifesting on the left side.Computed tomography angiography (cta) revealed a filling defect, indicating the presence of thrombus and plaque prolapse material within the stent lumen.Although the patient had passed the post-procedure neurological check, postoperative blood pressure exceeded 230 mmhg.Compliance with dual antiplatelet therapy (dapt) was confirmed; however, no p2y12 inhibitor test had been performed.The stent was subsequently explanted.Images of the explanted stent demonstrated plaque prolapse and platelet aggregates within the stent.The patient was reportedly doing well.

• 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: 23414453
• Report Number: 2124215-2025-75796
• Device Sequence Number: 16060261
• Product Code: NIM
• UDI-Device Identifier: 00811311020478
• UDI-Public: (01)00811311020478(17)270930(10)18380553
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 11/03/2025

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: SR-0840-CS
• Device Catalogue Number: SR-0840-CS
• Device Lot Number: 0018380553
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/03/2025
• Date Device Manufactured: 10/21/2024
• 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: 79 YR
• Patient Sex: Female