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

Model Number	SR-0930-CS
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent did not fully expand within the lumen, resulting in additional intervention.An enroute transcarotid stent was selected for use.The patient presented as symptomatic and had severe tortuosity in the distal internal carotid artery (ica).The patient underwent a successful transcarotid artery revascularization (tcar) procedure.However, there were some stent placement difficulties, when the patient wobbled during the procedure.The blood pressure of the patient was also very low.Post procedure the patient awoke fine.Hours later, it was reported that the patient had right sided weakness, hypotension, and was experiencing a possible trans ischemic attack (tia).It was suspected that the enroute 0.014 guidewire had gone sub-plaque in the common carotid artery (cca) and then back into the true lumen.Even though the guidewire did not behave in an odd fashion to indicate a dissection.The physician elected to perform a repeat ct which revealed no signs of stroke, but did reveal that the proximal portion of the stent appeared compressed, because the stent was placed partially in the atheroma.The distal portion of the stent was open.Later that day, the patient was returned to the operation room and repeat tcar was performed.An additional stent was placed over the dissection from the guidewire and to extend the stent father down where the proximal vasculature was healthy.The patient woke up from the procedure fine.
Event or Problem Description
It was reported that the stent did not fully expand within the lumen, resulting in additional intervention.An enroute transcarotid stent was selected for use.The patient presented as symptomatic and had severe tortuosity in the distal internal carotid artery (ica).The patient underwent a successful transcarotid artery revascularization (tcar) procedure.However, there were some stent placement difficulties, when the patient wobbled during the procedure.The blood pressure of the patient was also very low.Post procedure the patient awoke fine.Hours later, it was reported that the patient had right sided weakness, hypotension, and was experiencing a possible trans ischemic attack (tia).It was suspected that the enroute 0.014 guidewire had gone sub-plaque in the common carotid artery (cca) and then back into the true lumen.Even though the guidewire did not behave in an odd fashion to indicate a dissection.The physician elected to perform a repeat ct which revealed no signs of stroke, but did reveal that the proximal portion of the stent appeared compressed, because the stent was placed partially in the atheroma.The distal portion of the stent was open.Later that day, the patient was returned to the operation room and repeat tcar was performed.An additional stent was placed over the dissection from the guidewire and to extend the stent father down where the proximal vasculature was healthy.The patient woke up from the procedure fine.It was further reported that the patient presented as asymptomatic.

• 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: 22079507
• Report Number: 2124215-2025-33462
• Device Sequence Number: 12937230
• Product Code: NIM
• UDI-Device Identifier: 00811311020492
• UDI-Public: (01)00811311020492(17)270930(10)18376609
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 05/29/2025

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-0930-CS
• Device Catalogue Number: SR-0930-CS
• Device Lot Number: 0018376609
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 05/29/2025
• Date Device Manufactured: 10/09/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENROUTE 0.014 INCH GUIDEWIRE, BX/5; ENROUTE 0.014 INCH GUIDEWIRE, BX/5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Race: White