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

Model Number	SR-1030-CS
Medical Device Problem Codes	Positioning Problem (3009); Activation Failure (3270)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a stroke, requiring additional intervention.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.After the stent was placed, the physician was instructed to take an orthogonal view, but did not feel it was necessary.The stent appeared completely open.The patient went to the post anesthesia care unit (pacu) and was doing well the next morning.Post tcar procedure, the patient experienced a stroke.Subsequent imaging revealed calcification at the base of the stent, which impinged on the stent and prevented it from opening completely.Additionally, it was noted that the stent was positioned too high.The patient was transferred to another medical center, and the artery was revascularized with another stent.
Additional Manufacturer Narrative
We are unable to provide the complete unique identifier (udi) # for this product.All available product data has been included in this report.
Event or Problem Description
It was reported that the patient experienced a stroke, requiring additional intervention.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.After the stent was placed, the physician was instructed to take an orthogonal view, but did not feel it was necessary.The stent appeared completely open.The patient went to the post anesthesia care unit (pacu) and was doing well the next morning.Post tcar procedure, the patient experienced a stroke.Subsequent imaging revealed calcification at the base of the stent, which impinged on the stent and prevented it from opening completely.Additionally, it was noted that the stent was positioned too high.The patient was transferred to another medical center, and the artery was revascularized with another stent.
Additional Manufacturer Narrative
We are unable to provide the complete unique identifier (udi) # for this product.All available product data has been included in this report.Updated fields: h6 - evaluation method codes; evaluation conclusion codes.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 review of the enroute transcarotid stent device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of 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: 24314168
• Report Number: 2124215-2026-07699
• Device Sequence Number: 5650170
• Product Code: NIM
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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?: Yes
• 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 05/18/2026
• 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: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Race: White