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

Model Number SR-1040-CS

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

Patient Problems Brain Injury (2219); Convulsion/Seizure (4406)

Event Date 12/31/2020

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.A followup mdr will be submitted if additional information is obtained.Silk road medical will continue to monitor for occurrences of related events.Out of an abundance of caution, this complaint is being reported as it is unclear if the adverse event was caused by the procedure, a patient response, or the device.A secondary mdr is submitted under 3500a form # 3014526664-2021-00012 since at this time it is unknown which device may have caused or contributed to the reported event.

Event Description

It was reported that approximately two weeks after the completion of a transcarotid artery revascularization (tcar) procedure, the patient was hospitalized due to aphasia/seizures.The computed tomography angiography (cta) demonstrated critical stenosis.The physician removed the implanted stents during carotid repair to resolve the reported issue.There was no clinical hemispheric deficits but slow clearing encephalopathy.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEDICAL; 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 ; 4087309002
• MDR Report Key: 11219951
• MDR Text Key: 228415976
• Report Number: 3014526664-2021-00011
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020539
• UDI-Public: (01)00811311020539(17)211130(10)17918073
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: SR-1040-CS
• Device Catalogue Number: SR-1040-CS
• Device Lot Number: 17918073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2019
• 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: 64 YR