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

Model Number SR-0940-CS

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 10/24/2020

Event Type  Injury  

Manufacturer Narrative

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.Although there is no indication that a malfunction of the srm device occurred, the cause of the post-operative complication is unknown.A follow-up mdr will be submitted if additional information is obtained.Silk road medical will continue to monitor for occurrences of similar events.This event is being reported out of an abundance of caution.

Event Description

It was reported that after the completion of a transcarotid artery revascularization (tcar) procedure, the physician stated that the patient returned to the hospital due to a trans ischemic attack (tia).The physician stated that the patient experienced a thrombus which led to a thrombectomy.The stent looked completed thrombosed.After the patient returned from hospital they stopped taking plavix medication, and started brillinta and heparin.An x-ray performed showed minor cerebral hemorrhagic stroke.Neurologist recommended to stop all anti-coagulants for the time being.The patient will be tested for plavix resistance and plans to share the results as soon as they are made available.The tia the patient experienced self-resolved within 24 hours.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE SDS
• 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 ; 4087309002
• MDR Report Key: 10852255
• MDR Text Key: 216625391
• Report Number: 3014526664-2020-00112
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020508
• UDI-Public: (01)00811311020508(17)210731(10)17891023
• 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: 11/17/2020

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: 07/31/2021
• Device Model Number: SR-0940-CS
• Device Catalogue Number: SR-0940-CS
• Device Lot Number: 17891023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2020
• Initial Date FDA Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2019
• 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; Disability
• Patient Age: 75 YR