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

Model Number SR-0840-CS

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

Patient Problems Obstruction/Occlusion (2422); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Date 02/18/2022

Event Type  Injury  

Manufacturer Narrative

The product associated with this complaint was not returned to the manufacturer for analysis.The cause of the post-operative complication is unknown.Investigation is ongoing and results are not yet available.A follow-up mdr will be submitted when additional information is obtained.Silk road medical will continue to monitor for occurrences of similar events.

Event Description

It was reported that the following day after the transcarotid artery revascularization (tcar) procedure, the patient experienced an ischemic stroke.The patient also experienced left-sided weakness, in which symptoms improved but did not fully resolve within 24 hours.Computed tomography angiography (cta) and computed tomography (ct) perfusion scan revealed an occluded right carotid where the stent was located.The patient was placed on an oral anticoagulant and was discharged to acute rehabilitation.Additional information obtained indicated that the stent was ovalized, and thrombosis was noted beyond the ovalized segment.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: TSS
• 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: yvonne nguyen ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 13920954
• MDR Text Key: 288889685
• Report Number: 3014526664-2022-00035
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020478
• UDI-Public: (01)00811311020478(17)240331(10)18019123
• 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: 03/25/2022

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: 03/31/2024
• Device Model Number: SR-0840-CS
• Device Catalogue Number: SR-0840-CS
• Device Lot Number: 18019123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• 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): Disability; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male