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

Model Number	SR-0840-CS
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Difficult to Remove (1528); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was difficulty removing the stent delivery system.The patient presented as symptomatic.An enroute transcarotid stent system was selected for use for a right transcarotid revascularization (tcar) procedure.During the procedure, the stent failed to deploy as the surgeon unknowingly pinned the catheter near the sheath hub.After repositioning the delivery system, the interventional cardiologist attempted deployment but mistakenly pushed the hypotube forward instead of using the pin-and-pull technique, resulting in a broken hypotube and failed stent deployment.The physician proctor then recommended removing the delivery system.Resistance was felt during removal over the guidewire, but the delivery system was ultimately removed and found to be damaged.The device was exchanged, and a new stent was successfully deployed.The procedure was completed with no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the enroute transcarotid stent system (tss) was returned for analysis.During visual inspection, the shaft of the stent exhibited a separation on the outer shaft.
Event or Problem Description
It was reported that there was difficulty removing the stent delivery system.The patient presented as symptomatic.An enroute transcarotid stent system was selected for use for a right transcarotid revascularization (tcar) procedure.During the procedure, the stent failed to deploy as the surgeon unknowingly pinned the catheter near the sheath hub.After repositioning the delivery system, the interventional cardiologist attempted deployment but mistakenly pushed the hypotube forward instead of using the pin-and-pull technique, resulting in a broken hypotube and failed stent deployment.The physician proctor then recommended removing the delivery system.Resistance was felt during removal over the guidewire, but the delivery system was ultimately removed and found to be damaged.The device was exchanged, and a new stent was successfully deployed.The procedure was completed with no patient complications 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23301823
• Report Number: 2124215-2025-71992
• Device Sequence Number: 9926338
• Product Code: NIM
• UDI-Device Identifier: 00811311020478
• UDI-Public: (01)00811311020478(17)270930(10)18375102
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 12/16/2025

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: SR-0840-CS
• Device Catalogue Number: SR-0840-CS
• Device Lot Number: 0018375102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 82 KG