MAUDE Adverse Event Report: Silk Road Medical ENROUTE Transcarotid Stent; Stent, Carotid

Model Number	SR-1040-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cerebral Hyperperfusion Syndrome (4404); Hemorrhagic Stroke (4417)
Date of Event	06/18/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient experienced a hemorrhagic stroke.The patient also expired.The patient presented as asymptomatic for a right transcarotid revascularization (tcar) procedure.An enroute transcarotid stent (tss) system was selected for use.Prior to discharge, the patient experienced a hemorrhagic stroke.The patient subsequently died.The official cause of death was reported as hemorrhage.
Additional Manufacturer Narrative
B2: date of death was not reported; however, it has been estimated to have occurred in (b)(6) 2026.B3: date of event was not reported; however, it has been estimated to have occurred in (b)(6) 2026.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product lot number is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
B2: date of death was not reported; however, it has been estimated to have occurred in (b)(6) 2026.B3: date of event was not reported; however, it has been estimated to have occurred in (b)(6) 2026.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product lot number is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
B2: date of death was not reported; however, it has been estimated to have occurred on or after (b)(6) 2026, the date of the stroke.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product lot number is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient experienced a hemorrhagic stroke.The patient also expired.The patient presented as asymptomatic for a right transcarotid revascularization (tcar) procedure.An enroute transcarotid stent (tss) system was selected for use.Prior to discharge, the patient experienced a hemorrhagic stroke.The patient subsequently died.The official cause of death was reported as hemorrhage.
Event or Problem Description
It was reported that the patient experienced a hemorrhagic stroke.The patient also expired.The patient presented as asymptomatic for a right transcarotid revascularization (tcar) procedure.An enroute transcarotid stent (tss) system was selected for use.Prior to discharge, the patient experienced a hemorrhagic stroke.The patient subsequently died.The official cause of death was reported as hemorrhage.

• 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(763)494-1632
• MDR Report Key: 50092674
• Report Number: 2124215-2026-41109
• Device Sequence Number: 18600293
• Product Code: NIM
• UDI-Device Identifier: 00811311020539
• UDI-Public: (01)00811311020539
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 09/10/2026

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: SR-1040-CS
• Device Catalogue Number: SR-1040-CS
• 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: 06/18/2026
• Supplement Date Received by Manufacturer: 07/23/2026; 08/12/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/11/2026; 09/10/2026
• 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: 62 YR
• Patient Sex: Male