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

Model Number SR-1030-CS

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/01/2022

Event Type  Injury  

Manufacturer Narrative

The product associated with this complaint was not 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.At this time, it is unknown if the reported event is related to procedural issues, patient resistance or non-compliance to medication, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.A follow-up mdr will be submitted if additional information is obtained.Silk road medical will continue to monitor for occurrences of similar events.

Event Description

It was reported that following a transcarotid artery revascularization (tcar) procedure, the patient experienced neurological changes.Imaging revealed thrombus in the stent.The physician elected to re-line the stent with a 3rd party stent via transfemoral approach to address the issue.At this time, it is unknown if the reported event is related to procedural issues, patient resistance or non-compliance to medication, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE TSS
• 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: shelrin devi ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 17584980
• MDR Text Key: 321546853
• Report Number: 3014526664-2023-00133
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020522
• UDI-Public: (01)00811311020522(17)231130(10)17989790
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: SR-1030-CS
• Device Catalogue Number: SR-1030-CS
• Device Lot Number: 17989790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2020
• 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: 79 YR
• Patient Sex: Female