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

Model Number	SR-0830-CS
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent was surgically explanted.An enroute transcarotid stent was selected for use in the left sided transcarotid artery revascularization (tcar) procedure.The stent was deployed without issue, but the delivery system was unable to be removed.The physician used the 0.014 buddy wire technique, and post-dilated with another balloon.The physician moved the carotid artery medially and laterally while the anesthesiologist move the patient's head right and left with chin toward chest.The delivery system was still unable to be removed.The physician elected to convert the tcar procedure to a carotid endarterectomy (cea) and surgically explant the stent.The stent was removed in one piece, and there was no vessel trauma.Following the cea, the patient was neurologically intact.Removal difficulty was attributed to lesion characteristics.
Event or Problem Description
It was reported that the stent was surgically explanted.An enroute transcarotid stent was selected for use in the left sided transcarotid artery revascularization (tcar) procedure.The stent was deployed without issue, but the delivery system was unable to be removed.The physician used the 0.014 buddy wire technique, and post-dilated with another balloon.The physician moved the carotid artery medially and laterally while the anesthesiologist move the patient's head right and left with chin toward chest.The delivery system was still unable to be removed.The physician elected to convert the tcar procedure to a carotid endarterectomy (cea) and surgically explant the stent.The stent was removed in one piece, and there was no vessel trauma.Following the cea, the patient was neurologically intact.Removal difficulty was attributed to lesion characteristics.
Additional Manufacturer Narrative
Device analysis: an enroute transcarotid stent was returned for analysis.Visual analysis of the shaft of the stent delivery system revealed a separation on the outer shaft, as well as stent damage.The stent damage was a result of device explanation during during the procedure.

• 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: 22029777
• Report Number: 2124215-2025-31407
• Device Sequence Number: 15562624
• Product Code: NIM
• UDI-Device Identifier: 00811311020461
• UDI-Public: (01)00811311020461(17)260630(10)18225431
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/04/2025

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 Expiration Date: 06/30/2026
• Device Model Number: SR-0830-CS
• Device Catalogue Number: SR-0830-CS
• Device Lot Number: 0018225431
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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: 82 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Race: White