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

Model Number 9300TFX23

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem Aortic Insufficiency (1715)

Event Date 08/16/2016

Event Type  Injury  

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 nonfunctioning leaflet.Based on historical review of complaints, these events are typically a result of too ventricular deployment of the valve in combination with leaflet overhang.Other potential contributing factors include: leaflet impingement in a highly calcified 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 nonfunctioning 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 sapien xt valve motion restriction and subsequent central leak cannot be confirmed.It appears that the events were related to procedural factors.The device is not available for evaluation, as it remains in the patient.There is no allegation or indication that the events were related to a manufacturing defect.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.

Event Description

As reported by edwards affiliate in (b)(4), during a transfemoral valve-in-valve (23mm sapien xt into a failing 23mm carpentier edwards perimount magna bioprosthetic valve), moderate to severe aortic regurgitation (ar) was noted after valve deployment and a leaflet was thought to be stuck in the open position.Extensive efforts were used to dislodge the leaflet using a pigtail by manipulating the leaflets on the deployed valve without success.A second 23mm sapien xt valve was then prepared and deployed across the first valve.Repeat echo showed the ar had been eliminated, although moderate paravalvular leak remained, thought to be from the initial procedure.The patient left the room in stable condition.

Manufacturer Narrative

During the manufacturing process, all sapien xt valves are 100% visually inspected for defects and 100% tested for valve coaptation.This make it unlikely that a manufacturing defect or device malfunction would contributed to the event.In this case, the cause of the sapien xt valve motion restriction and subsequent central leak cannot be confirmed.In addition to procedural factors, over-inflation of the deployment balloon, inadequate pre-dilation of the native valve, slow recovery of adequate ventricular flow may have also contributed to the event.There is no allegation or indication that the events were related to a manufacturing defect.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 5943603
• MDR Text Key: 54471000
• Report Number: 2015691-2016-02717
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2016

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: 02/22/2018
• Device Model Number: 9300TFX23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/14/2016; 10/19/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2016
• 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
• Treatment: 23MM CARPENTIER EDWARDS PERIMOUNT MAGNA BIOPROSTHE
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR