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

Model Number	SR-0940-CS
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Headache (1880); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was in-folding.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.Post tcar procedure, the patient experienced a headache, and an additional computed tomography (ct) was performed.Hyper profusion and signs stroke were not identified and the headache resolved.Imaging did reveal that the stent had an in-fold appearance.Additional information provided by bsc senior medical director indicated that the common carotid artery, distal to the stented segment, had extensive disease.The patient had a history of thyroid surgery, and the neck was noted to be thick and likely fibrotic.The patient has untreated hepatitis c and human immunodeficiency virus (hiv), affecting the patient's vasculature.The stent collapsed due to thick tissue and not due to calcification.Medical management was performed as a result of the event and the patient is asymptomatic from the stent collapse.
Event or Problem Description
It was reported that the stent was in-folding.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.Post tcar procedure, the patient experienced a headache and an additional computed tomography (ct) was performed.Hyper profusion and signs stroke were not identified and the headache resolved.Imaging did reveal that the stent had an in-fold appearance.Additional information provided by boston scientfic (bsc) senior medical director indicated that the patients common carotid artery, distal to the stented segment, had extensive disease.The patient had a history of thyroid surgery, and the neck was noted to be thick and likely fibrotic.The patient has untreated hepatitis c and human immunodeficiency virus (hiv), affecting the patient's vasculature.The stent collapsed due to thick tissue and not due to calcification.Although the patient was reported to be asymptomatic from the stent collapse, the patient was treated with medication.The reason for medication being administered and the details of medication type and dose were not reported to bsc.
Additional Manufacturer Narrative
Updated fields: b1: adverse event/product problem.B5: describe event or problem.H6 - patient codes, impact codes, evaluation method codes; evaluation conclusion codes.

• 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: 22674793
• Report Number: 2124215-2025-48921
• Device Sequence Number: 3677623
• Product Code: NIM
• UDI-Device Identifier: 00811311020508
• UDI-Public: (01)00811311020508(17)270831(10)18365948
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 09/05/2025

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 Model Number: SR-0940-CS
• Device Catalogue Number: SR-0940-CS
• Device Lot Number: 0018365948
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/05/2025
• Date Device Manufactured: 09/06/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Race: White