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

Model Number SR-0940-CS

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

Patient Problem Vascular Dissection (3160)

Event Date 11/10/2021

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.Complaints will continue to be reviewed and monitored for trends.This report is for the enroute transcarotid stent system.A secondary mdr was reported under 3014526664-2021-00194 ((b)(4)) as it is unknown if the enroute 0.014" guidewire or the enroute transcarotid stent system caused the dissection.

Event Description

It was reported in a transcarotid artery revascularization (tcar) procedure, during final angiogram, a dissection was noticed on the common carotid artery which led to additional stent placement to cover the dissection.At this time, it is unknown if the enroute 0.014" guidewire or the enroute transcarotid stent system was the cause of the dissection.The procedure was completed successfully and the patient is neurologically intact.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: TSS
• Manufacturer (Section D): SILK ROAD MEDICAL INC; 1213 innsbruck drive; sunnyvale CA 94089 1317
• Manufacturer (Section G): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: jasneet bedi ; 1213 innsbruck drive; sunnyvale, CA 94089-1317 ; 4087209002
• MDR Report Key: 12973233
• MDR Text Key: 285318460
• Report Number: 3014526664-2021-00195
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020508
• UDI-Public: (01)00811311020508(17)240531(10)18029809
• 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: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: SR-0940-CS
• Device Catalogue Number: SR-0940-CS
• Device Lot Number: 18029809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• 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: 78 YR
• Patient Sex: Male