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

Model Number	SR-0940-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Hemorrhagic Stroke (4417)
Date of Event	06/03/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient experienced a brain bleed within 24 hours of the tcar procedure and subsequently passed away.The patient was presented as symptomatic with a very tight stenosis for a high surgical risk for the right-sided tcar procedure.The tcar procedure was completed.Following the procedure, according to the nurse practitioner, the patient received lovenox post-procedure.The patient was alert and following commands but exhibited signs of left arm weakness, which was present prior to the procedure, according to the physician.During the night, the patient developed a brain bleed, and the following morning, the family opted to replace the care consent with comfort care.A ct scan and neurology consultation were also conducted.The patient ultimately expired.

• 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: 22395410
• Report Number: 2124215-2025-42986
• Device Sequence Number: 18492049
• Product Code: NIM
• UDI-Device Identifier: 00811311020508
• UDI-Public: (01)00811311020508(17)270831(10)18365949
• 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
• Report Date (Section B): 07/03/2025

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: SR-0940-CS
• Device Catalogue Number: SR-0940-CS
• Device Lot Number: 0018365949
• 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: 06/03/2025
• Initial Report FDA Received Date: 07/03/2025
• 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: Death
• Patient Age: 77 YR
• Patient Sex: Male