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

Model Number SR-1040-CS

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 07/20/2020

Event Type  Injury  

Manufacturer Narrative

The product associated with this complaint was not returned to the manufacturer for analysis.An investigation into the reported event is underway and a follow up will be submitted once additional information is made available.

Event Description

A transcarotid artery revascularization (tcar) procedure was completed successfully in (b)(6) 2020.The patient returned in (b)(6) 2020 post-operative and showed seizure like symptoms upon hypotension noted by neurology and suggested hypoperfusion.A follow up ct scan was performed and showed narrowing in the enroute stent.A secondary (tcar) procedure was performed on (b)(6) 2020 where a hemashield dacron graft was placed at the proximal common carotid artery (cca).Noticeable stent fracture was seen on angio prior to (b)(6) 2020 angioplasty.Discussed adding a covered stent or additional enroute to cover fractures but physician opted angioplasty only.The patient woke up from surgery neurologically intact.As of the date of this report, there was no report of patient harm.

Manufacturer Narrative

The device investigation report was received and the following information was provided: a review of the manufacturing records and device history record (dhr) for this device was conducted and presented no issues during the manufacturing and inspection processes.A review of the lot did not yield any evidence that would support the conclusion that the stent involved in this complaint was nonconforming or that it contributed to the reported complaint.The review of the provided information such as photographs and lot history information concluded that there was no stent fracture and no issues were identified that could have led to the adverse event reported.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale, ca
• MDR Report Key: 10418131
• MDR Text Key: 203300629
• Report Number: 3014526664-2020-00073
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020539
• UDI-Public: (01)00811311020539(17)210430(10)17865037
• Combination Product (y/n): N
• PMA/PMN Number: P140026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: SR-1040-CS
• Device Catalogue Number: SR-1040-CS
• Device Lot Number: 17865037
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/17/2020
• Supplement Dates Manufacturer Received: 08/21/2020
• Supplement Dates FDA Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR