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

Model Number	SR-0930-CS
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	07/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product associated with this complaint could not be 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.Complaints will continue to be reviewed and monitored for trends.
Event or Problem Description
A transcarotid artery revascularization (tcar) procedure was completed successfully on (b)(6) 2020.The patient returned on july 29, 2020 for a stent that was severely compressed and near occlusive.Reportedly single plane full compression on ct scan with intraluminal thrombus and disease distal to stent that can be treated via carotid endarterectomy (cea).The patient sought a different surgeon, was seen as an outpatient in the office with upcoming explant scheduled, and is reportedly healthy with no current stroke symptoms.The calcium burden was not prohibitive prior to the case.The physician also used a 5x20 balloon for pre-dilatation and no post-dilatation was done.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale, ca
• MDR Report Key: 10455611
• Report Number: 3014526664-2020-00076
• Device Sequence Number: 3135141
• Product Code: NIM
• UDI-Device Identifier: 00811311020492
• UDI-Public: (01)00811311020492(17)210430(10)17865034
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2020

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: No Information
• Device Expiration Date: 04/30/2021
• Device Model Number: SR-0930-CS
• Device Catalogue Number: SR-0930-CS
• Device Lot Number: 17865034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/26/2020
• 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: Required Intervention