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

Model Number SR-0830-CS

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

Patient Problems Thrombosis (2100); Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 07/14/2018

Event Type  Injury  

Event Description

Procedure completed successfully on fri (b)(6) 2018.The next morning the patient's blood pressure had dropped after being given a calcium channel blocker for high blood pressure.The stent thrombosed shortly afterwards.Patient was brought to neuro-radiology intervention where the stent was declotted with a device which became stuck on the enroute stent edge.Vigorous attempts to dislodge the clotting catheter created a dissection which required a second stent to seal the dissection.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEDICAL; 735 north pastoria avenue; sunnyvale CA 94085
• Manufacturer (Section G): SILK ROAD MEDICAL; 735 north pastoria avenue; sunnyvale CA 94085
• Manufacturer Contact: branka spremo ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 7787955
• MDR Text Key: 117255687
• Report Number: 3007215228-2018-00021
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020461
• UDI-Public: (01)00811311020461(17)191031(10)201316
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2018

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: 10/31/2019
• Device Model Number: SR-0830-CS
• Device Catalogue Number: SR-0830-CS
• Device Lot Number: 201316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/14/2018
• 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: 59 YR