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	Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a right transcarotid artery revascularization (tcar) procedure, the patient woke up with left arm weakness.Imaging revealed acute stent thrombosis and the physician elected to perform thrombectomy.The patient was on dual antiplatelet therapy (dapt), and it is unclear if a p2y12 platelet function test was performed.Further, it was noted that the patient was hypotensive for approximately 6 minutes and had heart rate variability post tcar.The patient's symptoms have improved, but the patient had not made a complete recovery.At this time, it is unknown if the reported event is due to procedural issues, patient resistance to medication, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.
Additional Manufacturer Narrative
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 related to procedural issues, patient resistance to medication, or a silk road medical device failure, hence, the event will be reported out of 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.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: ENROUTE TSS
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck dr.; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL; 1213 innsbruck dr.; sunnyvale CA 94089
• Manufacturer Contact: vincent lopez mireles ; 1213 innsbruck dr.; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 19240073
• Report Number: 3014526664-2024-00088
• Device Sequence Number: 12636340
• Product Code: NIM
• UDI-Device Identifier: 00811311020539
• UDI-Public: (01)00811311020539(17)260630(10)18224574
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 05/03/2024

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: 06/30/2026
• Device Model Number: SR-1040-CS
• Device Catalogue Number: SR-1040-CS
• Device Lot Number: 18224574
• 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: 04/05/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2023
• 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: Required Intervention; Disability
• Patient Age: 62 YR
• Patient Sex: Male