MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX26A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Mitral Regurgitation (1964)

Event Date 12/04/2015

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is ongoing.

Event Description

On post-operative day (pod) 3, a 26mm sapien 3 valve was explanted from the mitral valve because one of its leaflets was not functioning properly.Off label case.A 26mm sapien 3 valve was implanted with the commander delivery system on the native mitral valve.It was a surgical procedure, a full sternotomy was performed and access was gained through the left atrium.The mitral valve was heavily calcified.The surgeon cut out part of the anterior mitral leaflet and debrided the calcification in the posterior mitral leaflet.Contrast solution was injected during balloon valvuloplasty with a 26 balloon and no leak was observed.The 26mm s3 valve was prepped with nominal volume and positioned under direct visual guidance.The s3 valve was deployed 40:60 atrial/ventricular, as intended.They used the s3 valve skirt to suture it in place.Post deployment the valve had trace paravalvular leak (pvl) and mild central leak.The patient was transferred in stable condition.It was reported that on pod-3 the s3 valve was explanted and replaced with a surgical valve because one of the leaflets was not working.

Manufacturer Narrative

(b)(4).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.The edwards sapien 3 transcatheter heart valve is indicated for patients with severe symptomatic calcified native aortic valve stenosis.Deployment of the s3 valve in a native mitral valve is not indicated per the labeling; therefore the labeling (ifus and ew training manuals) do not instruct the operator how to position the s3 valve in this scenario.In this particular case, despite multiple investigational attempts, it was not possible to obtain additional details regarding the valve explant procedure.The report of a non-functioning leaflet 3 days after implantation of the s3 valve was not confirmed.There is insufficient information to determine if the event was related to a device malfunction.However, the s3 valve was reportedly sutured in place in the native mitral valve.The valve is not available for evaluation.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 at this time.

• Brand Name: EDWARDS SAPIEN 3 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: frances preston, rn ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 5331504
• MDR Text Key: 34520213
• Report Number: 2015691-2015-03579
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2015

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: 10/26/2016
• Device Model Number: 9600TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2015
• 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: 55 YR