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

Model Number SR-0840-CS

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/22/2018

Event Type  malfunction  

Event Description

After normal deployment of the stent, physician withdrew delivery system and noticed the distal marker on the stent delivery system was still in the stent.He removed the stent delivery system completely and the distal clear tip on the stent delivery system was not there.He then went in with a 5mm gooseneck snare over a v18 wire and snared the distal end of the enroute.014 wire and successfully removed the enroute.014 wire with the loose tip on it.Patient was fine and stable.There was no calcium or tortuosity to cause the issue.The stent was prepped in normal fashion.The filter had a large piece of the plastic tip in it.

• 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; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: branka spremo ; 735 north pastoria avenue; sunnyvale, CA 94085 ; 4087209002
• MDR Report Key: 8426984
• MDR Text Key: 139069406
• Report Number: 3007215228-2019-00018
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020478
• UDI-Public: (01)00811311020478(17)190731(10)201042
• 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: 03/15/2018

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: 07/31/2019
• Device Model Number: SR-0840-CS
• Device Catalogue Number: SR-0840-CS
• Device Lot Number: 201042
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 03/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2017
• 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