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

Model Number	FG11815
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Muscle Weakness/Atrophy (1967); Dysphasia (2195); Ischemia Stroke (4418); Thrombosis/Thrombus (4440); Facial Paralysis (4585)
Date of Event	03/25/2026
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.An enroute transcarotid stent was selected for use in a right side transcarotid artery revascularization (tcar) procedure.The patient exhibited labile blood pressure during the procedure, ranging from 200mmhg to below 100mmhg.The procedure was completed with no other issues.Twenty-eight hours after the procedure, the patient experienced left side weakness, slurred speech and facial droop.Imaging performed reveled stent thrombosis.The patient is scheduled to transition to rehabilitation.
Event or Problem Description
It was reported that the patient experienced stent thrombosis.An enroute transcarotid stent was selected for use in a right side transcarotid artery revascularization (tcar) procedure.The patient exhibited labile blood pressure during the procedure, ranging from 200mmhg to below 100mmhg.The procedure was completed with no other issues.Twenty-eight hours after the procedure, the patient experienced left side weakness, slurred speech and facial droop.Imaging performed reveled stent thrombosis.The patient is scheduled to transition to rehabilitation.
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.Investigation results: ship history review: a ship history review for the reported upn was performed for the reporting customer.Batch 18433825 was most recently shipped to the reporting facility in the 3-year period preceding the procedure date.There were no manufacturing deviations for this batch number that could have contributed to the reported event.Device history record (dhr) review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.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 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: 24954770
• Report Number: 2124215-2026-21728
• Device Sequence Number: 5406223
• Product Code: NIM
• UDI-Device Identifier: 00811311021277
• UDI-Public: (01)00811311021277
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 07/01/2026

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: FG11815
• Device Catalogue Number: FG11815
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 07/01/2026
• 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
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Race: White