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	Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent occluded post tcar, resulting in hospitalization, and additional intervention.The patient presented to the hospital on (b)(6) 2025 with right side weakness and facial droop.The patient was admitted and had a massive watershed stroke that night.Anemic to 6, massive stroke, nih score 15.The surgeon waited over a week to do perform a left sided transcarotid artery revascularization (tcar) procedure due to the patient spiking a fever and uncontrolled systolic pressure.Systolic pressure went as high as 250 systolic when not on proper medications to control.On (b)(6) 2025, systolic was controlled, but it was difficult for anesthesia to get the pressure within the 140-160 target and required lots of medication.The patient had over 70% stenosis on both carotids.Act was over 250.The tcar procedure was completed with good results, and the stent was patent.The physician helped from the phone during the case and suggested keeping systolic pressure 100-140 post-procedure.Four hours post procedure, the stent occluded.Plavix resistance test was conducted, and the patient was normal.The physician suspected the occlusion could be from hypotension, because systolic was 80-90 on floor.The patient was transferred to a different hospital to be treated by a neuro radiologist.At the new facility, the patient underwent a thrombectomy.The patient did well and was discharged on (b)(6) 2025.On (b)(6) 2025, the patient presented to the emergency room with a massive brain bleed.The patient lost all brain activity and ultimately passed away.The physician suspected patient blood pressures were not maintained properly at the other hospital.
Event or Problem Description
It was reported that the stent occluded post tcar, resulting in hospitalization, additional intervention, and death.The patient presented to the hospital on (b)(6) 2025 with right side weakness and facial droop.The patient was admitted, and had a massive watershed stroke that night.Anemic to 6, massive stroke, nih score 15.The surgeon waited over a week to do perform a left sided transcarotid artery revascularization (tcar) procedure due to the patient spiking a fever and uncontrolled systolic pressure.Systolic pressure went as high as 250 systolic when not on proper medications to control.On (b)(6) 2025, systolic was controlled, but it was difficult for anesthesia to get the pressure within the 140-160 target, and required lots of medication.The patient had over 70% stenosis on both carotids.Act was over 250.The tcar procedure was completed with good results and the stent was patent.The physician helped from the phone during the case and suggested keeping systolic pressure 100-140 post-procedure.Four hours post procedure, the stent occluded.Plavix resistance test was conducted and the patient was normal.The physician suspected the occlusion could be from hypotension, because systolic was 80-90 on floor.The patient was transferred to a different hospital to be treated by a neuro radiologist.At the new facility, the patient underwent a thrombectomy.The patient did well and was discharged on (b)(6) 2025.On (b)(6) 2025, the patient presented to the emergency room with a massive brain bleed.The patient lost all brain activity and ultimately passed away.The physician suspected patient blood pressures were not maintained properly at the other hospital.
Additional Manufacturer Narrative
Updated fields: h6 - evaluation method codes, evaluation conclusion codes.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22155640
• Report Number: 2124215-2025-36823
• Device Sequence Number: 20709326
• Product Code: NIM
• UDI-Device Identifier: 00811311020478
• UDI-Public: (01)00811311020478(17)260228(10)18197260
• 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: 2025
• 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): 07/08/2025

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 Expiration Date: 02/28/2026
• Device Model Number: SR-0840-CS
• Device Catalogue Number: SR-0840-CS
• Device Lot Number: 0018197260
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/08/2025
• Date Device Manufactured: 03/01/2023
• 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; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Race: White