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

Model Number SR-0830-CS

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

This procedure utilized the stent in a manner for which it is not indicated.Out of an abundance of caution, this event has been reported.

Event Description

Patient had a tevar in 2014 with the proximal landing zone covering the subclavian artery.The subclavian never thrombosed off, and there was a large segment of thrombus sitting in the sc proximal to his left vertebral artery and lima (which was bypassed to his lad).Left axillary artery was exposed with cutdown and access with our enhance mpk and enroute nps arterial sheath was placed.Reverse flow was established with a venous sheath in the right femoral vein and proximal clamping of the axillary artery.The left vertebral artery was wired and a 6x30 enroute stent was placed.The goal was to snorkle the stent down into the subclavian towards the axillary artery to act as a filter for any potential thrombus.An additional stent (8x30) was laid proximally.Upon removing the second stent, the tip of the stent broke off -- the rest of the stent delivery system was removed from the patient, and we were able to visualize the distal radiopaque tip on the wire.A second wire was placed into the vertebral, and the sds tip was jailed with a mdt onyx coronary stent.Post stent angio showed flow to the brain stem.There were no eeg changes during the case, and the patient woke up neurologically intact.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: branka spremo ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 8446403
• MDR Text Key: 139707557
• Report Number: 3014526664-2019-00020
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020461
• UDI-Public: (01)00811311020461(17)200430(10)300241
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: SR-0830-CS
• Device Catalogue Number: SR-0830-CS
• Device Lot Number: 300241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR