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

Model Number	SR-0930-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product associated with this complaint was not returned to the manufacturer for analysis.A review of manufacturing records for this device was completed and no issues were identified that could have led to the adverse event reported.There is no indication that a malfunction of the srm device occurred.The cause of the post-operative complication is unknown.A follow-up mdr will be submitted if additional information is obtained.Silk road medical will continue to monitor for occurrences of similar events.
Event or Problem Description
It was reported after the completion of a right transcarotid artery revascularization (tcar) procedure, the patient experienced stroke like symptoms that included left side weakness lasting longer than 24 hours.A cta was performed showing acute stent thrombosis.No p2y12 inhibitor test was performed on the patient prior to the tcar procedure.This report is being submitted out of an abundance of caution, as it is unclear if the adverse event was caused by the procedure, patient response or the manufacturer's device.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: ENROUTE TSS
• Manufacturer (Section D): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyvale CA 94089 1317
• MDR Report Key: 12181677
• Report Number: 3014526664-2021-00105
• Device Sequence Number: 16845953
• Product Code: NIM
• UDI-Device Identifier: 00811311020492
• UDI-Public: (01)00811311020492(17)230731(10)301607
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2021

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: 07/31/2023
• Device Model Number: SR-0930-CS
• Device Catalogue Number: SR-0930-CS
• Device Lot Number: 301607
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 73 YR