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

Model Number SR-0640-CS

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

The product in complaint was not 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 lead to the adverse event reported.Complaints will continue to be monitored for any trends.

Event Description

It was reported that a (b)(6) male patient underwent a right transcarotid revascularization procedure on (b)(6) 2020.An extravasation occurred at the midportion of the 6x40 enroute stent.Therefore, a 6x2.5 viabhan stent was placed inside of the enroute stent which successfully stopped the leak.The physician took final images and everything appeared fine.No additional details were provided.

• 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, INC; 1213 innsbruck drive; sunnyvale, ca
• Manufacturer Contact: 1213 innsbruck drive; sunnyvale, ca
• MDR Report Key: 9724089
• MDR Text Key: 188712918
• Report Number: 3014526664-2020-00034
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020416
• UDI-Public: (01)00811311020416(17)210630(10)17880287
• 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: 02/18/2020

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: 06/30/2021
• Device Model Number: SR-0640-CS
• Device Catalogue Number: SR-0640-CS
• Device Lot Number: 17880287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 69 YR