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

Model Number SR-1040-CS

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Brain Injury (2219); Patient Problem/Medical Problem (2688)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

The product in complaint was not returned to the manufacturer for analysis.A review of the manufacturing records for this device was completed and no issues were identified that could have lead to the adverse event reported.Complaints will continue to be monitored for any trends.

Event Description

It was reported that a (b)(6) male underwent the tcar (trans carotid artery revascularization) procedure on (b)(6) 2019.During the procedure, somatosensory evoked potential (ssep) in the left hemisphere went off, however, electroencephalogram (eeg) showed no change.There was a 10 minute clamp time and blood pressure was systolic 90mmhg on closing.On wakening, the patient was not moving his left arm.Computed tomography angiograph (cta) was performed which showed acute stent recoil (without excessive calcium).The patient was brought back to the procedure room and the physician did a transfemoral angioplasty and the stent re-opened.A dwmri was also performed which showed multiple mirco peripheral infarction in watershed areas.It was conveyed that the procedure was successful.No additional details were provided.

Manufacturer Narrative

A user facility report was received by the manufacturer on 17oct2019 providing additional information.Please note that the sections below have been updated: date of birth weight, ethnicity, outcome attributed to adverse event, event description, relevant history, including preexisting medical conditions.

Event Description

User facility report was received by the manufacturer on 17oct2019, providing additional information that a ct scan was performed which showed that there was a right ica occlusion.The patient was emergently returned to the operating room.The occlusion was felt to be right of a complete stent collapse and kink at the level of the stenosis.The patient suffered a right sided cva with left hemiparesis.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEDICAL INC; 1213 innsbruck drive; sunnyvale CA 94089
• MDR Report Key: 8923841
• MDR Text Key: 156406709
• Report Number: 3014526664-2019-00060
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020539
• UDI-Public: (01)00811311020539(17)201231(10)300701
• Combination Product (y/n): N
• PMA/PMN Number: P140026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: SR-1040-CS
• Device Catalogue Number: SR-1040-CS
• Device Lot Number: 300701
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SR-200-NPS, LOT 300325
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Disability
• Patient Age: 66 YR
• Patient Weight: 76