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

Model Number SR-1040-CS

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

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

Event Date 05/07/2022

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.There is no indication that a malfunction of the srm device occurred; the cause of the post-operative complication is unknown, therefore, the complaint will be reported out of abundance of caution.Complaints will continue to be reviewed and monitored for trends.A supplemental mdr will be submitted if additional information is received.

Event Description

It was reported that a patient who received a transcarotid artery revascularization (tcar) procedure on (b)(6) 2022 returned to the emergency room on (b)(6) 2022 after experiencing stroke-like symptoms.Imaging revealed that the stent had thrombosed.The physician elected to perform an aspiration thrombectomy and implanted two stents to resolve the thrombosis.Patient was reported to be neurologically intact.At this time, there is no indications as to what may have caused the thrombus as the stent was not compromised and was fully expanded.There were no blood pressure issues noted.The patient was reported to be compliant with dual antiplatelet therapy, and plavix testing revealed no issues.Therefore, this event will be reported out of abundance of caution.

Manufacturer Narrative

Based on the information provided, a follow-up mdr is being submitted to remove the following fields: clinical code 4418 "ischemia stroke" under section h6: health effect - clinical code.The patient experienced a transient ischemic attack (tia), which does not meet the clinical definition of a stroke.Clinical code 4618 "permanent impairment" under section h6: health effect - impact code is being removed as the patient was reported to be neurologically intact post procedure.Outcomes attributed to adverse event: removed disability or permanent damage as the patient was reported to be neurologically intact post procedure.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE 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: magaly boardman ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 14552190
• MDR Text Key: 293077268
• Report Number: 3014526664-2022-00074
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020539
• UDI-Public: (01)00811311020539(17)240831(10)18055275
• 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,Followup
• Report Date: 09/02/2022

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 Model Number: SR-1040-CS
• Device Catalogue Number: SR-1040-CS
• Device Lot Number: 18055275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 05/08/2022
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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; Disability
• Patient Age: 78 YR
• Patient Sex: Female