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

Model Number SR-0940-CS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932)

Event Date 07/27/2020

Event Type  Injury  

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.Although there is no indication that a malfunction of the srm device occurred, the cause of the post-operative complication is unknown.This is very rare and there are a few case reports in the published literature.This is the first adverse event that silk road medical has received related to infection.Additionally, cordis, manufacturer of precise carotid stent has not seen a stent infection since precise was launched.A follow-up mdr will be submitted if additional information is obtained.Silk road medical will continue to monitor for occurrences of infection events.

Event Description

It was reported that a patient returned to the emergency hospital due to headaches on (b)(6) 2020.A ct scan determined that the area of the patients right transcarotid artery revascularization (tcar) looked compromised and infected.The physician performed an open carotid procedure and the stent/area around the stent was infected.There was a large area of pus and other material, inflammation and other indicators of infection.The stent was removed and a vein was used to repair the carotid artery.The patient is doing well.The original tcar procedure was performed on (b)(6) 2020.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEDICAL INC; 1213 innsbruck drive; sunnyvale, ca
• Manufacturer (Section G): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale, ca
• Manufacturer Contact: magaly boardman ; 1213 innsbruck drive; sunnyvale, ca ; 7209002
• MDR Report Key: 10455606
• MDR Text Key: 204418667
• Report Number: 3014526664-2020-00075
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 0081131020508
• UDI-Public: (01)0081131020508(17)210430(10)17866341
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• 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-0940-CS
• Device Catalogue Number: SR-0940-CS
• Device Lot Number: 17866341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR