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

Model Number SR-0930-CS

Device Problem Collapse (1099)

Patient Problem Occlusion (1984)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

The product associated with this complaint could not be 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 led to the adverse event reported.Complaints will continue to be reviewed and monitored for trends.

Event Description

A transcarotid artery revascularization (tcar) procedure was completed successfully on (b)(6) 2020.The patient returned on july 29, 2020 for a stent that was severely compressed and near occlusive.Reportedly single plane full compression on ct scan with intraluminal thrombus and disease distal to stent that can be treated via carotid endarterectomy (cea).The patient sought a different surgeon, was seen as an outpatient in the office with upcoming explant scheduled, and is reportedly healthy with no current stroke symptoms.The calcium burden was not prohibitive prior to the case.The physician also used a 5x20 balloon for pre-dilatation and no post-dilatation was done.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale, ca
• Manufacturer (Section G): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale, ca
• Manufacturer Contact: magaly boardman ; 1213 innsbruck drive; sunnyvale, ca ; 7209002
• MDR Report Key: 10455611
• MDR Text Key: 204428941
• Report Number: 3014526664-2020-00076
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020492
• UDI-Public: (01)00811311020492(17)210430(10)17865034
• 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: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/30/2021
• Device Model Number: SR-0930-CS
• Device Catalogue Number: SR-0930-CS
• Device Lot Number: 17865034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2019
• 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