MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9000TFX23A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Aortic Regurgitation (1716)

Event Date 05/23/2014

Event Type  Injury  

Event Description

During a transaortic tavr procedure, post deployment the 23mm sapien valve position was 50:50 but there was moderate-severe central aortic insufficiency (cai).It was observed that the anterior leaflet was not moving.The patient was stable before deployment; post deployment the patient was hypotensive due to the cai.The physician tried some troubleshooting maneuvers, but the leaflet still did not move, so it was decided to place a 2nd valve.The 2nd 23mm sapien valve was implanted in the same position as the 1st one resolving the issue.It is unknown why the anterior leaflet was not moving.The patient was stable at the end of the procedure.

Manufacturer Narrative

There are several potential patient and procedural factors that alone or in combination can cause or contribute to a report of a restricted or non-functioning leaflet.Based on historical review of complaints, these events are typically a result of too ventricular deployment of the valve in combination with native leaflet overhang.Other potential contributing factors include: leaflet impingement in a highly calcified native valve, impingement of a leaflet due to the guide wire, or slow recovery of adequate ventricular flow post valve deployment and rapid pacing.This can result in a temporary decrease in the pressure gradient between the ventricle and the aorta, resulting in an inadequate pressure change to close the leaflets.In many instances this can be overcome with trouble shooting, which includes blood pressure recovery or support.Occasionally there are cases where the root cause of the non-functioning leaflet cannot be determined.During the manufacturing process, all edwards valves are 100% visually inspected for defects and 100% tested for coaptation prior to release for distribution.This makes it highly unlikely that a manufacturing defect or device malfunction would contribute to the event.In this case, the cause of the reported non functioning leaflet and cai post deployment of the sapien valve cannot be determined.Imaging of the procedure was not available for edwards lifesciences to review.Without imaging, patient factors (native leaflet calcification), and procedural factors (imaging intensifier angle, valve deployment position, confirmation of leaflet overhang) could not be confirmed/assessed.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

• Brand Name: EDWARDS SAPIEN TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: deborah deutsch ; 1 edwards way; irvine, CA 92614 ; 9497564213
• MDR Report Key: 3884405
• MDR Text Key: 21804020
• Report Number: 2015691-2014-01411
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2014

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: 04/27/2016
• Device Model Number: 9000TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2014
• Initial Date FDA Received: 06/19/2014
• Date Device Manufactured: 05/07/2014
• 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: 83 YR