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

Model Number SR-0840-CS

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

Patient Problems Thrombosis (2100); Thrombus (2101); Brain Injury (2219)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

The device was implanted in the patient and therefore, it was not available for evaluation.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

A tcar procedure was performed.Patient was on aspirin, plavix and statin.After ballooning the left internal carotid artery to the common carotid artery with one inflation, the balloon was taken out and a stent was placed into the target area.The patient started to not respond to questions and it was decided to quickly complete the procedure.Reverse flow went for 3 minutes after the stent deployment.After one view of the stent, the stent looked patent so the physician took the enroute nps off and completed the tcar procedure.The patient regained her ability to respond to questions as well as the movements in her hands and feet.Two views of the brain were taken and the brain was patent.Later that day, patient's stent occluded and the patient had a stroke.The patient ended up going to the interventional neurology where the stent was suctioned and the thrombus removed.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEDICAL, INC.; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL, INC.; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: mai-ly wilcox ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 8685320
• MDR Text Key: 147569364
• Report Number: 3014526664-2019-00039
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020478
• UDI-Public: (01)00811311020478(17)200131(10)201382
• 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: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• 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-0840-CS
• Device Catalogue Number: SR-0840-CS
• Device Lot Number: 201382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2018
• 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: 73 YR