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

Model Number	SR-0830-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Brain Injury (2219); Thrombosis/Thrombus (4440)
Date of Event	11/20/2020
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.The collapsed stent has not been able to be confirmed, nor has imaging been provided.Additioonally, no device has been returned for evaluation.Although 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 that three days after the completion of a transcarotid artery revascularization (tcar) procedure, the patient experienced sudden onset of weakness and slurred speech.The patient was taken to the emergency room where a stroke was confirmed and re-admitted to the hospital where it was reported that the stent collapsed in the center and the stent had thrombus.The physician performed a thrombectomy, followed by angioplasty, and a secondary 8x30 stent was placed to resolve the reported issue.It was reported that the patients medication was switched from plavix to brillinta.Multiple attempts were made to gather additional information regarding the reported event however no further information was made available.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyvale CA 94089
• MDR Report Key: 11029485
• Report Number: 3014526664-2020-00124
• Device Sequence Number: 13751303
• Product Code: NIM
• UDI-Device Identifier: 00811311020461
• UDI-Public: (01)00811311020461(17)211231(10)17926325
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: SR-0830-CS
• Device Catalogue Number: SR-0830-CS
• Device Lot Number: 17926325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 12/17/2020
• 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: 77 YR