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	Muscle Weakness/Atrophy (1967); Obstruction/Occlusion (2422); Ischemia Stroke (4418)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced an embolic stroke.An enroute transcarotid neuroprotection system was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.It was reported that the patient was previously symptomatic in right hemisphere.The physician was using neuroimaging/neuromonitoring (evaluation of motor functions) during the tcar procedure.The final completion angiogram showed plaque prolapse; therefore, a second stent to was added to reline the first stent.Neuromonitoring went off to the left arm and left leg during placement of the second stent.Approximately one hour post procedure, as the patient was waking up, the patient experienced left arm weakness.Magnetic resonance imaging (mri) revealed that the patient had experienced a right sided embolic stroke.The patient was admitted to the hospital beyond the standard of care.No intervention was required due to the stroke event.
Additional Manufacturer Narrative
Updated fields: e1- initial reporter email.H6- evaluation method codes; evaluation conclusion codes.
Event or Problem Description
It was reported that the patient experienced an embolic stroke.An enroute transcarotid neuroprotection system was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.It was reported that the patient was previously symptomatic in right hemisphere.The physician was using neuroimaging/neuromonitoring (evaluation of motor functions) during the tcar procedure.The final completion angiogram showed plaque prolapse; therefore, a second stent to was added to reline the first stent.Neuromonitoring went off to the left arm and left leg during placement of the second stent.Approximately one hour post procedure, as the patient was waking up, the patient experienced left arm weakness.Magnetic resonance imaging (mri) revealed that the patient had experienced a right sided embolic stroke.The patient was admitted to the hospital beyond the standard of care.No intervention was required due to the stroke event.
Additional Manufacturer Narrative
Updated fields: h6- patient codes, impact codes: addition of e2328 and f2301 to better capture the reported event of plaque prolapse and the additional stent placed.
Event or Problem Description
It was reported that the patient experienced an embolic stroke.An enroute transcarotid neuroprotection system was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.It was reported that the patient was previously symptomatic in right hemisphere.The physician was using neuroimaging/neuromonitoring (evaluation of motor functions) during the tcar procedure.The final completion angiogram showed plaque prolapse; therefore, a second stent to was added to reline the first stent.Neuromonitoring went off to the left arm and left leg during placement of the second stent.Approximately one hour post procedure, as the patient was waking up, the patient experienced left arm weakness.Magnetic resonance imaging (mri) revealed that the patient had experienced a right sided embolic stroke.The patient was admitted to the hospital beyond the standard of care.No intervention was required due to the stroke 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22913822
• Report Number: 2124215-2025-60367
• Device Sequence Number: 18405785
• Product Code: NIM
• UDI-Device Identifier: 00811311020539
• UDI-Public: (01)00811311020539(17)270630(10)18343187
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 01/23/2026

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
• Device Lot Number: 0018343187
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 09/26/2025; 01/23/2026
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/23/2025; 01/23/2026
• Date Device Manufactured: 07/15/2024
• 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: 77 YR
• Patient Sex: Male
• Patient Race: Black Or African American