MAUDE Adverse Event Report: SILK ROAD MEDICAL ENROUTE TRANSCAROTID STENT SYSTEM; ENROUTE TSS

Catalog Number	SR-0740-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a right transcarotid artery revascularization (tcar) procedure, the patient passed the post procedure neurological check but later the patient experienced hypotension with systolic pressures ranging in the 70's-60's, became incoherent, and was unable to follow commands.Imaging revealed an occluded stent with thrombus.The physician elected to explant the stent and performed a carotid artery endarterectomy (cea) with a patch angioplasty.During stent explant, the patient experienced hypertension with systolic pressures ranging in the 80s - 220s systolic.After the stent explant, the patient suffered a hemorrhagic stroke.The patient is currently in an induced coma.The hemorrhagic stroke was determined by the physician to be due to the patient's high blood pressure and not due to the tcar procedure.Additional information stated that the patient had a transient ischemic attack (tia) one week prior to the tcar procedure.No further information is available.At this time, it is unknown if the reported event of an occluded stent and subsequent stroke is due to procedural issues, patient resistance to medication or a silk road medical device, hence it will be reported out of an abundance of caution.
Additional Manufacturer Narrative
The product associated with this complaint was not returned to the manufacturer for analysis.A review of the manufacturing records for this device was completed and no issues were identified that could have led to the adverse event reported.At this time, it is unknown if the reported event of an occluded stent and subsequent stroke is due to procedural issues, patient resistance to medication or a silk road medical device, hence it will be reported out of an abundance of caution.Complaints will continue to be reviewed and monitored for trends.All reasonably available information has been provided by the company at the time of submission of this report.The fields that are blank are not an omission and indicate that the information is either not applicable or currently unavailable.If additional information is received, a supplemental report will be filed.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: ENROUTE TSS
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck dr.; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL; 1213 innsbruck dr.; sunnyvale CA 94089
• Manufacturer Contact: vincent lopez mireles ; 1213 innsbruck dr.; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 21528472
• Report Number: 3014526664-2025-00038
• Device Sequence Number: 15857822
• Product Code: NIM
• UDI-Device Identifier: 00811311020447
• UDI-Public: (01)00811311020447(17)250531(10)18116184
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2025

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: 05/31/2025
• Device Catalogue Number: SR-0740-CS
• Device Lot Number: 18116184
• 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: 02/08/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2022
• 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; Disability
• Patient Age: 81 YR
• Patient Sex: Male