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	Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was also not provided to bsc.We made a good-faith effort to obtain this information.Because the lot number is unknown at this time, we are unable to provide the complete unique device identifier (udi) and other specific product details.If additional information becomes available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient vessel was occluded requiring additional intervention.An enroute transcarotid stent was selected for use in a left side transcarotid artery revascularization (tcar) procedure.The procedure was completed with no notable issues.Post procedure, the patient experienced right arm weakness which the physician attributed to a previous right sided stroke.Imaging performed revealed no new white lesions, but did reveal some contained low-density material, consistent with possible plaque prolapse and possible thrombus.The stent was explanted and an endarterectomy was performed.No further information was provided regarding patient outcome despite request by boston scientific (bsc).
Additional Manufacturer Narrative
The lot number was also not provided to bsc.We made a good-faith effort to obtain this information.Because the lot number is unknown at this time, we are unable to provide the complete unique device identifier (udi) and other specific product details.If additional information becomes available, a supplemental report will be submitted.Investigation results: labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: 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.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.
Event or Problem Description
It was reported that the patient vessel was occluded requiring additional intervention.An enroute transcarotid stent was selected for use in a left side transcarotid artery revascularization (tcar) procedure.The procedure was completed with no notable issues.Post procedure, the patient experienced right arm weakness which the physician attributed to a previous right sided stroke.Imaging performed revealed no new white lesions, but did reveal some contained low-density material, consistent with possible plaque prolapse and possible thrombus.The stent was explanted and an endarterectomy was performed.No further information was provided regarding patient outcome despite request by boston scientific (bsc).

• 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: 25233465
• Report Number: 2124215-2026-27252
• Device Sequence Number: 20110929
• Product Code: NIM
• UDI-Device Identifier: 00811311020478
• UDI-Public: (01)00811311020478
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 07/16/2026

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-0840-CS
• Device Catalogue Number: SR-0840-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: 04/22/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 07/16/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male