MAUDE Adverse Event Report: Silk Road Medical ENROUTE Transcarotid Neuroprotection System; Embolic protection filtering guidewire

Model Number	FG12531
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the numerical markings 1, 2, and 3 were not present on the arterial sheath prior to the procedure.An enroute transcarotid neuroprotection system was selected for use in a transcarotid artery revascularization (tcar) procedure.Upon removal of the sheath stopper for tunneling and before the arterial sheath was inserted into the patient, it was observed that the numerical pad-printed markings 1, 2, and 3 were not present on the sheath.The procedure was completed with the same device with no reported patient complications.No evidence of flaking was observed.The patient was stable post procedure.

• Brand Name: ENROUTE Transcarotid Neuroprotection System
• Common Device Name: Embolic protection filtering guidewire
• 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 ; +1(763)494-1632
• MDR Report Key: 50085704
• Report Number: 2124215-2026-40924
• Device Sequence Number: 18761714
• Product Code: NTE
• UDI-Device Identifier: 00811311021062
• UDI-Public: (01)00811311021062(11)240813(10)306232
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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: FG12531
• Device Catalogue Number: FG12531
• Device Lot Number: 0000306232
• 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: 04/16/2026
• Initial Report FDA Received Date: 07/30/2026
• Date Device Manufactured: 08/13/2024
• 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: 83 YR
• Patient Sex: Unknown