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	Stroke/CVA (1770); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the timeline for the stroke event in relation to the tcar procedure is unknown, the event could not be attributed to either the enroute stent or the enroute neuroprotection system (nps).As a most-likely device could not be determined, an mdr is being reported for both devices.Please see mdr 2124215-2025-64583, which captures the enroute nps used during this procedure.B3: date of event: the event date was approximated to the date bsc became aware of the event, 08/19/2025.D6a: implant date: the implant date was approximated to the date bsc became aware of the event, 08/19/2025.Details of the event, including patient status and product information, were not provided to bsc.We completed a good faith effort to obtain the information.Because the product lot is unknown at this time, we are unable to provide the complete unique identifier (udi) number 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 had a stroke post procedure.An enroute transcarotid stent was selected for use in the right transcarotid artery revascularization (tcar) procedure.It was reported by the physician that sometime after the procedure, the patient had a stroke.At this time, it is unknown when the stroke event occurred or if any intervention was performed.No further information was available to boston scientific.
Additional Manufacturer Narrative
Further information was received for the stroke timeline which attributes the stroke to the enroute neuroprotection system (nps) which is captured in mdr report number 2124215-2025-64583.Since the timeline for the stroke event in relation to the tcar procedure is unknown, the event could not be attributed to either the enroute stent or the enroute neuroprotection system (nps).As a most-likely device could not be determined, an mdr is being reported for both devices.Please see mdr 2124215-2025-64583, which captures the enroute nps used during this procedure.B3 - date of event: the event date was approximated to the date bsc became aware of the event, 08/19/2025.D6a - implant date: the implant date was approximated to the date bsc became aware of the event, 08/19/2025.Details of the event, including patient status and product information, were not provided to bsc.We completed a good faith effort to obtain the information.Because the product lot is unknown at this time, we are unable to provide the complete unique identifier (udi) number 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 had a stroke post procedure.An enroute transcarotid stent was selected for use in the right transcarotid artery revascularization (tcar) procedure.It was reported by the physician that sometime after the procedure, the patient had a stroke.At this time, it is unknown when the stroke event occurred or if any intervention was performed.No further information was available to boston scientific.

• 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: 23058147
• Report Number: 2124215-2025-64592
• Device Sequence Number: 15828635
• Product Code: NIM
• UDI-Device Identifier: 00811311021314
• UDI-Public: (01)00811311021314(17)280131(10)18422737
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: 0018422737
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/17/2025
• Date Device Manufactured: 03/01/2025
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Race: White