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

Model Number SR-1040-CS

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

Patient Problems Dysphasia (2195); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Date 01/10/2024

Event Type  Injury  

Event Description

It was reported that after a left transcarotid artery revascularization (tcar) procedure, the patient was aphasic and had an ischemic stroke.Imaging revealed left sided scattered acute infarcts (new white lesions) and low density material within the stent that could be potentially thrombus.The patient's symptoms have not yet resolved and no additional intervention was performed.At this time, it is unknown if the reported event is related to procedural issues or a silk road medical device failure, hence, the event will be reported out of abundance of caution.

Manufacturer Narrative

A secondary mdr was reported under 3014526664-2024-00023 as there were two products associated with this event.The product associated with this complaint was not returned to the manufacturer for analysis.A review of 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 failure is related to procedural issues or a silk road medical device failure, hence, the event will be reported out of abundance of caution.Silk road medical will continue to monitor for occurrences of similar events.All reasonably available information has been provided by the company at the time of submission of this report.The fields that are blank are not an omission and indicate that the information is either not applicable or currently unavailable.If additional information is received, a supplemental report will be filed.

• 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: 18673344
• MDR Text Key: 334950939
• Report Number: 3014526664-2024-00040
• Device Sequence Number: 1
• Product Code: NIM
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• 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: 18213031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2023
• 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
• Patient Age: 86 YR
• Patient Sex: Male