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

Model Number	FG11815
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent tip was damaged.An enroute transcarotid stent was selected for use in the left sided transcarotid artery revascularization (tcar) procedure.The target lesion was highly calcified, with 85-90% calcification and no tortuosity.Cutdown and carotid access was obtained successfully without complications, and the arterial sheath was placed in the left common carotid.An enroute 0.014 guidewire was used to wire the lesion.A 6x30 non-boston scientific balloon was inserted over the wire and, percutaneous transluminal angioplasty (pta) was performed.A waist was identified with the initial pta, so the 6x30 was removed over the wire and an unknown 6x20 balloon was inserted, and pta was repeated.At this time, the 9-7mm x 40mm enroute stent was inserted over the wire.The stent would not advance through the lesion.An additional enroute 0.014 guidewire was inserted as a buddy wire beside the existing wire.The stent was again advanced and yet again did not pass through the lesion.Multiple attempts to advance the stent through the lesion were made without success.The buddy wire was then removed.The stent delivery system was inserted and attempted to advance, but the stent was unable to cross the lesion.The device was removed, and upon inspection, it was noted that the stent tip appeared sharp and blunt.The device was exchanged to complete the procedure, and there were no patient complications as a result of the device malfunction.

• 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: 22181599
• Report Number: 2124215-2025-38095
• Device Sequence Number: 8401829
• Product Code: NIM
• UDI-Device Identifier: 00811311021291
• UDI-Public: (01)00811311021291(17)271031(10)18389418
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG11815
• Device Catalogue Number: FG11815
• Device Lot Number: 0018389418
• 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: 05/13/2025
• Initial Report FDA Received Date: 06/10/2025
• Date Device Manufactured: 11/15/2024
• 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
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Race: White