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

Model Number	SR-0830-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); Dysphasia (2195); Obstruction/Occlusion (2422)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced stroke post procedure.An enroute transcarotid stent was selected for use in a left side transcarotid artery revascularization (tcar) procedure.Due to the soft characteristics of the patient's plaque, a second stent was placed.The procedure was completed with no notable issues.Next morning, the patient experienced right arm weakness and aphasia.Imaging performed revealed a small amount of low-density material (a narrow rim) within the stent, and the hounsfield units were consistent with plaque prolapse.It was also noted that the activated clotting time (act) was not in range.The patient remained hospitalized beyond the standard of care.There was no p2y12 test performed but the patient was switched to 100 mg aspirin and brilinta.The patient symptoms had improved but not completely resolved the following day, and they were discharged to continue to heal at home.
Event or Problem Description
It was reported that a patient experienced stroke post procedure; an enroute transcarotid stent was selected for use in a left side transcarotid artery revascularization (tcar) procedure.Due to the soft characteristics of the patients plaque, a second stent was placed.The procedure was completed with no notable issues.Next morning, the patient experienced right arm weakness and aphasia.Imaging performed revealed a small amount of low-density material (a narrow rim) within the stent, and the hounsfield units were consistent with plaque prolapse.It was also noted that the activated clotting time (act) was not in range.The patient remained hospitalized beyond the standard of care.There was no p2y12 test performed but the patient was switched to 100 mg aspirin and brilinta.The patient symptoms had improved but not completely resolved the following day, and they were discharged to continue to heal at home.
Additional Manufacturer Narrative
Investigation results: the device was not returned for analysis, as it is still implanted.It was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.A risk review performed for the enroute transcarotid stent device confirmed that the events of stroke/cva, muscle weakness, dysphasia and obstruction/ occlusion are known events defined in the product risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint the most probable cause for this complaint was considered known inherent risk of device.

• 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 ; 7634941632
• MDR Report Key: 24471446
• Report Number: 2124215-2026-11056
• Device Sequence Number: 9644326
• Product Code: NIM
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 05/12/2026

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-0830-CS
• Device Catalogue Number: SR-0830-CS
• Device Lot Number: 0018395168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 05/12/2026
• Date Device Manufactured: 11/28/2024
• 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: 79 YR
• Patient Sex: Male
• Patient Race: White