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); Patient Problem/Medical Problem (2688)

Event Date 08/15/2019

Event Type  Injury  

Manufacturer Narrative

The product in complaint was not returned to the manufacturer for analysis.Therefore, the root cause of this adverse event cannot be identified at this time.If the device should become available or additional information is obtained a supplemental report will be provided.Additionally, this was the first reported adverse event of this nature associated with this lot.Complaints will continue to be monitored for any trends.Please see related mfr report 3014526664-2019-00065.

Event Description

It was reported that a transcarotid artery revascularization (tcar) procedure was performed on an (b)(6) year old symptomatic male on rica/rcca lesion on (b)(6) 2019.The patient had a history of lymphoma with dxrt and experienced an episode of left sided weakness the morning of the procedure.The initial procedure was performed with good results and the patient woke from ga maex4 and was responsive.A silk road medical area manager at the hospital was notified that the patient was being brought back to the hospital for a new episode of left sided weakness.A computed tomography angiography (cta) was performed which showed no new white lesions.A ct brain scan was also performed which showed that the brain was normal.An ultrasound showed that the stents had thrombosed.The patient was then treated using nps for flow reversal in conjunction with penumbra aspiration catheter for clot removal.Frothy pink/red material was removed.An 8 x 50 viabahn was then deployed and flow was restored.Patient was doing well after the procedure and had no new weakness or other signs of stroke at that time.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 94089
• Manufacturer (Section G): SILK ROAD MEDICAL, INC; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: 1213 innsbruck drive; sunnyvale, CA 94089
• MDR Report Key: 8986404
• MDR Text Key: 161565681
• Report Number: 3014526664-2019-00066
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020478
• UDI-Public: (01)00811311020478(17)200430(10)300247
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: SR-0840-CS
• Device Catalogue Number: SR-0840-CS
• Device Lot Number: 300247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR