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

Model Number SR-1040-CS

Device Problem Accessory Incompatible (1004)

Patient Problem Great Vessel Perforation (2152)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

In discussions with the silk road executive medical director, the extravasation being reported was due to a series of events.First, the lesion that was to be treated was highly calcified and not suitable for stenting.Second, the post-dilatation was very aggressive, forcing the stent against the calcified lesion.The end result was extravasation of the vessel.There have been only 8 extravasations reported in more than 16,000 transcarotid artery revascularization procedures.Complaint data will continue to be monitored for trends of extravasation.

Event Description

Patient underwent a left transcarotid artery revascularization.Patient had pre-dilatation with 6x30mm rapid exchange balloon followed by a successful delivery of a 10x40mm enroute stent.Following angiogram showed mild stenosis and post-dilatation was performed with 7x20mm rx balloon.Following angiogram showed extravasation of contrast at the distal portion of the stent.A 8x39mm gore viabahn vbx balloon expandable stent was placed at the distal portion of the enroute stent with approximately 1 cm overlap.Following angiogram showed improvement of extravasation.Patient woke up post-operatively at baseline mental status, following all verbal commands as well as moving all extremities appropriately to verbal commands.Follow up with surgeon the following morning, he reported the patient to be doing well with mild confusion which he attributed to her advanced age.

• Brand Name: ENROUTE TANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEDICAL, INC.; 1213 innsbruck drive; sunnyvale, ca
• Manufacturer (Section G): SILK ROAD MEDICAL, INC.; 1213 innsbruck drive; sunnyvale, ca
• Manufacturer Contact: sharon rideout ; 1213 innsbruck drive; sunnyvale, ca ; 7209002
• MDR Report Key: 10204438
• MDR Text Key: 199898547
• Report Number: 3014526664-2020-00060
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020539
• UDI-Public: (01)00811311020539(17)210930(10)17902998
• 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: 06/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: SR-1040-CS
• Device Catalogue Number: SR-1040-CS
• Device Lot Number: 17902998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2019
• 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: 89 YR