MAUDE Adverse Event Report: SILK ROAD MEDICAL ENROUTE TRANSCAROTID STENT SYSTEM; ENROUTE TSS

Model Number	SR-1040-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Dysphasia (2195); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
For section a2, the exact patient's age is unknown; however, it was reported that the age range is 75-79 years.The product associated with this complaint was not returned to the manufacturer for analysis.A review of the manufacturing records for this device was completed and no issues were identified that could have led to the adverse event reported.At this time, it is unknown if the reported event is due to dapt nonadherence, resistance to medication, patient's underlying condition or a silk road medical device and will be reported out of an abundance of caution.Complaints will continue to be reviewed and monitored for trends.All reasonably available information has been provided by the company at the time of submission of this report.The fields that are blank are not an omission and indicate that the information is either not applicable or currently unavailable.If additional information is received, a supplemental report will be filed.
Event or Problem Description
It was reported that approximately 50 days after a left tcar procedure, the patient was found unresponsive and drooling.This patient was symptomatic from a middle cerebral artery (mca) region stroke prior to transcarotid artery revascularization procedure.Imaging revealed intraluminal thrombotic debris within the stent.The patient was admitted to a stroke rehabilitation facility and continued to exhibit stroke symptoms (word finding and weakness).It was also reported that the patient had a bradycardic event in the rehabilitation facility, however no additional information was provided.Additionally, it was noted that this patient was on triple therapy post tcar procedure (eliquis, aspirin and plavix) and had discontinued aspirin three weeks post procedure.The patient was resumed on aspirin and prescribed brilinta.The patient's symptoms have not yet resolved.At this time, it is unknown if the reported event is related to dapt non-adherence, patient's underlying condition, resistance to medication or a silk road medical device, hence, this event will be reported out of an abundance of caution.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: ENROUTE TSS
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: shelrin devi ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 19347672
• Report Number: 3014526664-2024-00100
• Device Sequence Number: 6493084
• Product Code: NIM
• UDI-Device Identifier: 00811311020539
• UDI-Public: (01)00811311020539(17)251231(10)18174997
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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 Expiration Date: 12/31/2025
• Device Model Number: SR-1040-CS
• Device Catalogue Number: SR-1040-CS
• Device Lot Number: 18174997
• 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: 04/25/2024
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2023
• 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: Disability
• Patient Sex: Male