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	Confusion/ Disorientation (2553); Unspecified Tissue Injury (4559)
Date of Event	04/23/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
H6.Patient codes: e2015 insufficient information is used as the cause of death is unknown.
Event or Problem Description
It was reported that the patient died three days after the procedure.An enroute transcarotid stent was selected for use in the left transcarotid artery revascularization (tcar) procedure.Post procedure, the patient was slow to wake up which was attributed to age and the patient was sent to post-anesthesia care unit (pacu).Three days after the procedure, it was reported that the patient had passed away.Additionally, it was also reported that the patient had chronic kidney disease (ckd) and chronic obstructive pulmonary disease (copd).At this time, the patient's cause of death is unknown, and further information is not available.
Event or Problem Description
It was reported that the patient died three days after the procedure.An enroute transcarotid stent was selected for use in the left transcarotid artery revascularization (tcar) procedure.Post procedure, the patient was slow to wake up which was attributed to age and the patient was sent to post-anesthesia care unit (pacu).Three days after the procedure, it was reported that the patient had passed away.Additionally, it was also reported that the patient had chronic kidney disease (ckd) and chronic obstructive pulmonary disease (copd).At this time, the patient's cause of death is unknown, and further information is not available.
Additional Manufacturer Narrative
Investigation results: 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 does not represent a new or unanticipated risk.These event types were accounted for during the product risk analysis to support an acceptable risk benefit for the product.Based on a thorough review of the reported complaint the most probable cause for this complaint was considered no problem detected.---------------------------------------------------------------------------------- h6.Patient codes: e2015 insufficient information is used as the cause of death is unknown.

• 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): CORDIS US CORP; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 25449552
• Report Number: 2124215-2026-30828
• Device Sequence Number: 9551487
• Product Code: NIM
• UDI-Device Identifier: 00811311021291
• UDI-Public: (01)00811311021291(17)281031(10)18527705
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2026

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: 0018527705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 08/25/2026
• Date Device Manufactured: 11/15/2025
• 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: Death
• Patient Age: 84 YR
• Patient Sex: Male