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

Model Number	SR-0930-CS
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device encountered resistance upon advancement and difficulty during removal.The patient presented as asymptomatic for a left transcarotid artery revascularization (tcar) procedure.The treated vessel exhibited severe calcification, and vessel tortuosity was described as mild.The target lesion demonstrated approximately 90% stenosis.The enroute transcarotid stent system (tss) was selected for use.During the procedure, the physician inserted the delivery system into the sheath and, as it exited the sheath tip, felt resistance.The physician reported that removal difficulty was not related to vessel anatomy or lesion characteristics.Fluoroscopy confirmed that the stent had not deployed.The physician applied additional force but was unable to advance the delivery system and subsequently attempted to withdraw it, at which point the delivery system was noted to be stuck on the wire.The delivery system and guidewire were removed together as a unit, after which the physician removed the delivery system from the guidewire outside the body using hemostats and force.The physician exchanged the device and successfully advanced and deployed a stent in the internal carotid artery.No patient complications were reported.

• 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: 24859472
• Report Number: 2124215-2026-19763
• Device Sequence Number: 15712550
• Product Code: NIM
• UDI-Device Identifier: 00811311020492
• UDI-Public: (01)00811311020492(17)270731(10)18357347
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup,Followup
• Report Date (Section B): 07/09/2026

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: SR-0930-CS
• Device Catalogue Number: SR-0930-CS
• Device Lot Number: 0018357347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 05/21/2026; 07/02/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 06/16/2026; 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2024
• 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: 77 YR
• Patient Sex: Male