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

Model Number SR-0830-CS

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

Patient Problems Thrombosis (2100); Patient Problem/Medical Problem (2688)

Event Date 01/17/2019

Event Type  Injury  

Event Description

Tcar performed.Once patient reached recovery room, right side weak.Patient returned to procedure room and stent was occluded.Cea was performed and stents were explanted.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEIDCAL; 735 north pastoria avenue; sunnyvale CA 94085
• Manufacturer (Section G): SILK ROAD MEDICAL; 735 north pastoria avenue; sunnyvale CA 94085
• Manufacturer Contact: branka spremo ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 8423247
• MDR Text Key: 138891796
• Report Number: 3007215228-2019-00012
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020461
• UDI-Public: (01)00811311020461(17)200131(10)201383
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2019

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: 01/31/2020
• Device Model Number: SR-0830-CS
• Device Catalogue Number: SR-0830-CS
• Device Lot Number: 201383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2018
• 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: 72 YR