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

Model Number	FG11815
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a dissection occurred, which was treated using an additional stent.An enroute transcarotid stent was selected for use in the left sided transcarotid artery revascularization (tcar) procedure.After the initial tcar procedure, the patient awoke and was unable to move his right arm.The surgeon elected to re-open the patient and perform another tcar.He believed the stented portion needed to extend into the common carotid artery (cca).The surgeon accessed the cca and reviewed the external and internal carotid arteries along with the brain from imaging.He stated everything looked good, and there were no blockages in the stent or the cranial vessels.However, the surgeon did suspect there might be a dissection at the bifurcation of the carotid.A third stent was placed to cover the dissection.There were no further patient complications as a result of the dissection.
Additional Manufacturer Narrative
Updated fields: h6 - evaluation method codes, evaluation conclusion codes.
Event or Problem Description
It was reported that a dissection occurred, which was treated using an additional stent.An enroute transcarotid stent was selected for use in the left sided transcarotid artery revascularization (tcar) procedure.After the initial tcar procedure, the patient awoke and was unable to move his right arm.The surgeon elected to re-open the patient and perform another tcar.He believed the stented portion needed to extend into the common carotid artery (cca).The surgeon accessed the cca, and reviewed the external and internal carotid arteries along with the brain from imaging.He stated everything looked good, and there were no blockages in the stent or the cranial vessels.However, the surgeon did suspect there might be a dissection at the bifurcation of the carotid.A third stent was placed to cover the dissection.There were no further patient complications as a result of the dissection.
Additional Manufacturer Narrative
Updated fields: e1 - initial reporter email.
Event or Problem Description
It was reported that a dissection occurred, which was treated using an additional stent.An enroute transcarotid stent was selected for use in the left sided transcarotid artery revascularization (tcar) procedure.After the initial tcar procedure, the patient awoke and was unable to move his right arm.The surgeon elected to re-open the patient and perform another tcar.He believed the stented portion needed to extend into the common carotid artery (cca).The surgeon accessed the cca, and reviewed the external and internal carotid arteries along with the brain from imaging.He stated everything looked good, and there were no blockages in the stent or the cranial vessels.However, the surgeon did suspect there might be a dissection at the bifurcation of the carotid.A third stent was placed to cover the dissection.There were no further patient complications as a result of the dissection.

• 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: 22288595
• Report Number: 2124215-2025-40224
• Device Sequence Number: 12992232
• Product Code: NIM
• UDI-Device Identifier: 00811311021277
• UDI-Public: (01)00811311021277(17)280131(10)18414347
• 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: 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,Followup
• Report Date (Section B): 12/02/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: FG11815
• Device Catalogue Number: FG11815
• Device Lot Number: 0018414347
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 11/04/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/18/2025; 12/02/2025
• Date Device Manufactured: 02/05/2025
• 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: 86 YR
• Patient Sex: Male
• Patient Race: White