MAUDE Adverse Event Report: Silk Road Medical ENROUTE Transcarotid Stent; Stent, Carotid

Model Number	FG11815
Medical Device Problem Codes	Use of Device Problem (1670); Positioning Problem (3009)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Vascular Dissection (3160); Ischemia Stroke (4418)
Date of Event	07/30/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient developed an occlusion secondary to a dissection, requiring additional intervention.The patient subsequently suffered a stroke and later died.The patient presented as symptomatic for a left transcarotid artery revascularization (tcar) procedure.An enroute transcarotid stent system (tss) was selected for use.Following the procedure, imaging reportedly demonstrated sluggish flow toward the distal circulation; however, the flow was determined as acceptable, and the patient was closed.The patient later became symptomatic, and computed tomography angiography (cta) identified occlusion of the left internal carotid artery (ica) at the petrous and cavernous segments.A thrombectomy was performed but did not improve the patient's symptoms.Subsequently, stent removal and carotid endarterectomy (cea) were performed.A repeat cta reportedly demonstrated ica dissection and a non-occlusive stroke, after which the patient was placed on comfort care.A subsequent cta reportedly showed ischemic changes in the left frontal lobe.The patient later died, and the official cause of death not provided.Further review of the cta images dated (b)(6) 2026 identified contrast filling a crescent-shaped true lumen while the stents were positioned behind it within a non-flowing dissection plane.The first stent in the common carotid artery and the overlapping second stent were both located outside the true lumen, with no filling of the ica beyond the occlusion.

• 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): CORDIS US CORP; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50703260
• Report Number: 2124215-2026-48350
• Device Sequence Number: 18563172
• Product Code: NIM
• UDI-Device Identifier: 00811311021314
• UDI-Public: (01)00811311021314(17)290131(10)18553909
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: FG11815
• Device Catalogue Number: FG11815
• Device Lot Number: 0018553909
• 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: 08/13/2026
• Initial Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 02/16/2026
• 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: Death; Required Intervention; Other
• Patient Age: 83 YR
• Patient Sex: Male