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 Vascular Dissection (3160)

Event Date 06/09/2020

Event Type  Injury  

Manufacturer Narrative

The product associated with this complaint could not be returned to the manufacturer for analysis.Dissection is a known adverse event associated with tcar procedures.Complaints will continue to be reviewed and monitored for trends.

Event Description

The patient underwent a left transcarotid artery revascularization.A 9x40 stent was placed in the left internal carotid artery and a post-dilation was conducted with a 5x30 balloon.It was suspected that an arterial intimal flap at the distal portion of the stent was created.An overlapping 7x30 stent was placed distal to the original stent to treat the dissection.Angiogram was performed and the suspected intimal flap was no longer visible.The patient was monitored with eeg during the procedure which indicated no waveform changes.Patient awoke from anesthesia alert and oriented and passed all neurological exams.

• Brand Name: ENROUTE TRANSCAROTID 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: 10245648
• MDR Text Key: 197966427
• Report Number: 3014526664-2020-00063
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020508
• UDI-Public: (01)00811311020508(17)210531(10)17871459
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P1400026
• 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: 07/08/2020

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: 05/31/2021
• Device Model Number: SR-0940-CS
• Device Catalogue Number: SR-0940-CS
• Device Lot Number: 17871469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2019
• 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
• Patient Age: 70 YR