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	Low Blood Pressure/ Hypotension (1914); Inflammation (1932); Paralysis (1997); Cerebral Edema (4403); Cerebral Hyperperfusion Syndrome (4404); Hemorrhagic Stroke (4417); Reperfusion Injury (4851)
Date of Event	05/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a hemorrhagic stroke the day following the procedure.Additional reported complications included paralysis and edema, inflammation, and swelling.The patient presented as symptomatic for a left transcarotid revascularization (tcar) procedure.An enroute transcarotid stent system (tss) was selected for use.The patient reportedly passed the post-procedure neurological check; however, the following day, the patient experienced a hemorrhagic stroke with paralysis and edema/inflammation/swelling.The patient was reportedly restarted on lovenox the evening after the tcar procedure.Due to the swelling, the patient reportedly required a craniotomy.Additional information obtained indicated that the patient was believed to be on triple therapy and was hypotensive post-procedure, requiring vasopressor support.The patient was transported from recovery to the neuro intensive care unit, where postoperative care was managed.It was suspected that standard unit order sets may have been implemented, resulting in the patient receiving lovenox.The event was described as a reperfusion 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 ; +1(612)875-7234
• MDR Report Key: 25340877
• Report Number: 2124215-2026-29071
• Device Sequence Number: 5290425
• Product Code: NIM
• UDI-Device Identifier: 00811311021314
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Followup
• Report Date (Section B): 09/22/2026

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: 0018454820
• 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: 05/04/2026
• Supplement Date Received by Manufacturer: 07/14/2026; 08/24/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 07/17/2026; 09/22/2026
• Date Device Manufactured: 05/27/2025
• 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; Other
• Patient Age: 60 YR
• Patient Sex: Male