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

Catalog Number	SR-090740-TCS
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On february 03, 2025, a medwatch report#: (b)(4) was received via email.The following information was provided on the medwatch report: stent failure / patient need to return to surgery - and left explant of internal carotid artery stent, carotid artery endarterectomy with bovine pericardial patch angioplasty.It was reported that after a left transcarotid artery revascularization (tcar) procedure, the patient experienced stroke symptoms and the stent was identified to be deformed.The physician elected to explant the stent and perform a carotid artery endarterectomy (cea) with a bovine pericardial patch angioplasty.At this time, it is unknown if the reported stroke event is related to procedural issues, patient resistance or non-compliance to medication, or a silk road medical device, however, this event will be reported for the enroute transcarotid stent system (tss) 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 stroke event is related to procedural issues, patient resistance or non-compliance to medication, or a silk road medical device, however, this event will be reported for the enroute transcarotid stent system (tss) 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: 21360647
• Report Number: 3014526664-2025-00021
• Device Sequence Number: 18263089
• Product Code: NIM
• UDI-Device Identifier: 00811311021291
• UDI-Public: (01)00811311021291(17)270331(10)18308170
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/11/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SR-090740-TCS
• Device Lot Number: 18308170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2024
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White