MAUDE Adverse Event Report: SILK ROAD MEDICAL ENROUTE TRANSCAROTID STENT; STENT, CAROTID

Model Number	SR-0940-CS
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent was placed outside of the target lesion, resulting in device explant and additional intervention.An enroute transcarotid stent was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.It was reported that during the procedure, while trying to engage the external carotid artery (eca), the 0.035" j-tip guidewire inadvertently moved likely causing an injury to the vessel.An enroute 0.014 guidewire was used to wire the internal carotid artery (ica) but it could not cross the lesion, a v-14 guidewire was used successfully and stent was placed.Final imaging revealed that the stent was placed outside the ica.The physician explanted the stent and noted that the stent had perforated the ica.The physician performed a carotid endarterectomy (cea) and placed a patch to treat the perforation.The patient was expected to fully recover.
Additional Manufacturer Narrative
Investigation results: the device was not returned for analysis, as it was discarded.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 reported event is a known event defined in the product risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered known inherent risk of device.
Event or Problem Description
It was reported that the stent was placed outside of the target lesion, resulting in device explant and additional intervention.An enroute transcarotid stent was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.It was reported that during the procedure, while trying to engage the external carotid artery (eca), the 0.035" j-tip guidewire inadvertently moved likely causing an injury to the vessel.An enroute 0.014 guidewire was used to wire the internal carotid artery (ica) but it could not cross the lesion, a v-14 guidewire was used successfully and stent was placed.Final imaging revealed that the stent was placed outside the ica.The physician explanted the stent and noted that the stent had perforated the ica.The physician performed a carotid endarterectomy (cea) and placed a patch to treat the perforation.The patient was expected to fully recover.

• 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 ; 7634941632
• MDR Report Key: 24420915
• Report Number: 2124215-2026-09899
• Device Sequence Number: 12232291
• Product Code: NIM
• UDI-Device Identifier: 00811311020508
• UDI-Public: (01)00811311020508(17)270731(10)18352048
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 04/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SR-0940-CS
• Device Catalogue Number: SR-0940-CS
• Device Lot Number: 0018352048
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/13/2026
• Date Device Manufactured: 08/05/2024
• 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: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male