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); Intracranial Hemorrhage (1891); High Blood Pressure/ Hypertension (1908); Hemorrhagic Stroke (4417)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a hemorrhagic stroke after the procedure.An enroute transcarotid neuroprotection system (nps) was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.During flow reversal, as the patient's right hemisphere was functionally isolated, blood pressures were elevated to around 180mmhg to support flow reversal.The procedure was completed with no notable issues.Later that same day, the patient developed a subarachnoid hemorrhage and was transferred to another hospital.Further imaging also revealed intraventricular bleeding.The physician placed a ventricular shunt in the right lateral ventricle to treat the event.
Additional Manufacturer Narrative
Corrected fields: b5 - device type mentioned corrected to enroute transcarotid stent.Investigation results: the device was not returned for analysis, as it is still implanted.A review of the manufacturing documentation associated with this lot was performed, and it was found that one defective unit was rejected during the final assembly of this lot.It was confirmed that the unit was properly segregated and discarded.No manufacturing deviations were identified that could be related to the reported complaint.The review did not suggest that the adverse event experienced by the customer could be related to the manufacturing process.Review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.A risk review performed for the enroute transcarotid stent device confirmed that the events of hemorrhagic stroke, hypertension, hemorrhage, major, and hemorrhage, subarachnoid are known events defined in the product risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint the most probable cause for this complaint was considered known inherent risk of device.
Event or Problem Description
It was reported that the patient experienced a hemorrhagic stroke after the procedure.An enroute transcarotid stent was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.During flow reversal, as the patient's right hemisphere was functionally isolated, blood pressures were elevated to around 180mmhg to support flow reversal.The procedure was completed with no notable issues.Later that same day, the patient developed a subarachnoid hemorrhage and was transferred to another hospital.Further imaging also revealed intraventricular bleeding.The physician placed a ventricular shunt in the right lateral ventricle to treat the event.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24236132
• Report Number: 2124215-2026-05797
• Device Sequence Number: 15749121
• Product Code: NIM
• UDI-Device Identifier: 00811311021291
• UDI-Public: (01)00811311021291(17)280229(10)18425095
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 03/30/2026

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: 0018425095
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 03/04/2025
• 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; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Race: White