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); Hemorrhagic Stroke (4417)
Date of Event	08/29/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the patient experienced a hemorrhagic stroke.An enroute transcarotid stent was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.During the tcar procedure, the patient's blood pressure was within range per the instruction for use however, the patients blood pressure spiked significantly during induction of general anesthesia and at the time of carotid cut down.After the procedure, the patients blood pressure remained high, and they were unable to be extubated.The physician elected to re-enter the vessel through the groin to evaluate the stent which was patent and imaging revealed a hemorrhagic stroke.No intervention was performed and the patient died on (b)(6) 2025.
Additional Manufacturer Narrative
Updated fields: h6 - evaluation method codes; evaluation conclusion codes.E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the patient experienced a hemorrhagic stroke.An enroute transcarotid stent was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.During the tcar procedure, the patient's blood pressure was within range per the instruction for use however, the patients blood pressure spiked significantly during induction of general anesthesia and at the time of carotid cut down.After the procedure, the patients blood pressure remained high, and they were unable to be extubated.The physician elected to re-enter the vessel through the groin to evaluate the stent which was patent and imaging revealed a hemorrhagic stroke.No intervention was performed and the patient died on (b)(6) 2025.

• 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: 23149836
• Report Number: 2124215-2025-67251
• Device Sequence Number: 16095184
• Product Code: NIM
• UDI-Device Identifier: 00811311021260
• UDI-Public: (01)00811311021260(17)270731(10)18358121
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 12/09/2025

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 Model Number: FG11815
• Device Catalogue Number: FG11815
• Device Lot Number: 0018358121
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 12/09/2025
• Date Device Manufactured: 08/19/2024
• 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: Death; Other
• Patient Age: 70 YR
• Patient Sex: Female