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

Model Number	SR-0840-CS
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent was inadvertently deployed in the external carotid, requiring additional surgical intervention.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.The surgeon accessed the vessel, and the lesion was predilated.The stent was deployed.At this point, it was observed that the stent was inadvertently deployed in the left external carotid rather than the left internal carotid.The left external carotid ran alongside the left internal carotid and both took the same bend.As a result, the external carotid was opened and the stent was removed.The procedure was converted to a carotid endarterectomy (cea).The patient was reported as stable and did well post-procedure.The patient was discharged home with no complications.
Additional Manufacturer Narrative
Updated fields: h6 - evaluation method codes, evaluation conclusion codes.
Event or Problem Description
It was reported that the stent was inadvertently deployed in the external carotid, requiring additional surgical intervention.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.The surgeon accessed the vessel, and the lesion was predilated.The stent was deployed.At this point, it was observed that the stent was inadvertently deployed in the left external carotid rather than the left internal carotid.The left external carotid ran alongside the left internal carotid and both took the same bend.As a result, the external carotid was opened and the stent was removed.The procedure was converted to a carotid endarterectomy (cea).The patient was reported as stable and did well post-procedure.The patient was discharged home with no complications.

• 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: 22159157
• Report Number: 2124215-2025-37092
• Device Sequence Number: 12972244
• Product Code: NIM
• UDI-Device Identifier: 00811311020478
• UDI-Public: (01)00811311020478(17)270930(10)18380554
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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
• Report Date (Section B): 07/08/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SR-0840-CS
• Device Catalogue Number: SR-0840-CS
• Device Lot Number: 0018380554
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/08/2025
• Date Device Manufactured: 10/21/2024
• 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: 69 YR
• Patient Sex: Female
• Patient Race: White