MAUDE Adverse Event Report: Silk Road Medical ENROUTE Transcarotid Stent; Stent, Carotid

Model Number	SR-1030-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Muscle Weakness/Atrophy (1967); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	08/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product lot number is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient experienced stent thrombosis requiring additional intervention.\ \ an enroute transcarotid stent was selected for use in a left side transcarotid artery revascularization (tcar) procedure.The physician placed a stent only in the internal carotid artery (ica) and did not extend it into the common carotid artery (cca).Post procedure, when the patient was being transferred to post anesthesia care unit (pacu), the patient was not moving any extremities and was not following commands.The patient had a stroke and the stent was thrombosed.The physician performed a thrombectomy and extended an additional stent into the cca.Further image review also revealed occlusion at the bifurcation.Additional information received indicated that the patient symptoms were slowly resolving and the left side of the body was at baseline.Patient still could not move their right arm.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50765895
• Report Number: 2124215-2026-49067
• Device Sequence Number: 9148797
• Product Code: NIM
• UDI-Device Identifier: 00811311020522
• UDI-Public: (01)00811311020522
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: SR-1030-CS
• Device Catalogue Number: SR-1030-CS
• 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: 08/17/2026
• Initial Report FDA Received Date: 09/14/2026
• 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: 71 YR
• Patient Sex: Male