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

Model Number	SR-0730-CS
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced stroke-like symptoms 1 week post t-car, and the stent appeared narrowed.Two enroute transcarotid stents was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.There were no issues with the stents expanding noted during the procedure or in post procedure imaging.One week following the tcar procedure, the patient presented to the er with stroke-like symptoms.The patient was transferred to a different facility, and the physician had limited access to additional information.The physician was able to report that one of the stents appeared narrowed.No further information was available, despite request by boston scientific.
Event or Problem Description
It was reported that the patient experienced stroke-like symptoms 1 week post tcar, and the stent appeared narrowed.Two enroute transcarotid stents was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.There were no issues with the stents expanding noted during the procedure or in post procedure imaging.One week following the tcar procedure, the patient presented to the er with stroke-like symptoms.The patient was transferred to a different facility, and the physician had limited access to additional information.The physician was able to report that one of the stents appeared narrowed.No further information was available, despite request by boston scientific.
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: 22159367
• Report Number: 2124215-2025-35394
• Device Sequence Number: 12992041
• Product Code: NIM
• UDI-Device Identifier: 00811311020430
• UDI-Public: (01)00811311020430(17)260930(10)18250082
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: SR-0730-CS
• Device Catalogue Number: SR-0730-CS
• Device Lot Number: 0018250082
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/08/2025
• Date Device Manufactured: 10/01/2023
• 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: Hospitalization; Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Race: White