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	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Hemorrhagic Stroke (4417)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Was reported that after a transcarotid artery revascularization (tcar) procedure, the patient experienced hypotension and a hemorrhagic stroke.An enroute transcarotid stent was selected for use in a right sided tcar procedure.The procedure was performed according to plan with no notable issues.Post procedure, the patient was showing signs of hypotension and was treated for that.Approximately 3-4 hours post tcar, the patient began to experience stroke symptoms.The patient was taken for a computed tomography (ct), which revealed a subarachnoid bleed in addition to what was believed to be an active subclavian vein bleed.The patient was returned to the operating room, where it was confirmed that the subclavian artery was not the source of bleeding.Instead, the bleeding was localized to the surgical cutdown site.The surgeon had made a slightly lateral incision, which may have resulted in an inadvertent nick to the subclavian vein during vascular access.Additional information indicated that the patient was on triple therapy; eliquis (for pre-existing atrial fibrillation), aspirin, and clopidogrel, and it was suggested that aspirin was the most likely contributor to the bleeding complication.At the time of reporting, the patient was neurologically intact.
Event or Problem Description
Was reported that after a transcarotid artery revascularization (tcar) procedure, the patient experienced hypotension and a hemorrhagic stroke.An enroute transcarotid stent was selected for use in a right sided tcar procedure.The procedure was performed according to plan with no notable issues.Post procedure, the patient was showing signs of hypotension and was treated for that.Approximately 3-4 hours post tcar, the patient began to experience stroke symptoms.The patient was taken for a computed tomography (ct), which revealed a subarachnoid bleed in addition to what was believed to be an active subclavian vein bleed.The patient was returned to the operating room, where it was confirmed that the subclavian artery was not the source of bleeding.Instead, the bleeding was localized to the surgical cutdown site.The surgeon had made a slightly lateral incision, which may have resulted in an inadvertent nick to the subclavian vein during vascular access.Additional information indicated that the patient was on triple therapy; eliquis (for pre-existing atrial fibrillation), aspirin, and clopidogrel, and it was suggested that aspirin was the most likely contributor to the bleeding complication.At the time of reporting, the patient was neurologically intact.
Additional Manufacturer Narrative
Updated fields: h6 - evaluation method codes; evaluation conclusion codes.
Additional Manufacturer Narrative
Updated field: e1- initial reporter email.
Event or Problem Description
It was reported that after a transcarotid artery revascularization (tcar) procedure, the patient experienced hypotension and a hemorrhagic stroke.An enroute transcarotid stent was selected for use in a right sided tcar procedure.The procedure was performed according to plan with no notable issues.Post procedure, the patient was showing signs of hypotension and was treated for that.Approximately 3-4 hours post tcar, the patient began to experience stroke symptoms.The patient was taken for a computed tomography (ct), which revealed a subarachnoid bleed in addition to what was believed to be an active subclavian vein bleed.The patient was returned to the operating room, where it was confirmed that the subclavian artery was not the source of bleeding.Instead, the bleeding was localized to the surgical cutdown site.The surgeon had made a slightly lateral incision, which may have resulted in an inadvertent nick to the subclavian vein during vascular access.Additional information indicated that the patient was on triple therapy; eliquis (for pre-existing atrial fibrillation), aspirin, and clopidogrel, and it was suggested that aspirin was the most likely contributor to the bleeding complication.At the time of reporting, the patient was neurologically intact.

• 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: 22731251
• Report Number: 2124215-2025-51702
• Device Sequence Number: 8419082
• Product Code: NIM
• UDI-Device Identifier: 00811311021277
• UDI-Public: (01)00811311021277(17)261031(10)18262659
• 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,Followup
• Report Date (Section B): 11/12/2025

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: 0018262659
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 09/02/2025; 10/14/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/29/2025; 11/12/2025
• Date Device Manufactured: 11/01/2023
• 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: Other
• Patient Age: 85 YR
• Patient Sex: Female