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

Model Number 9600TFX26J

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Aortic Regurgitation (1716)

Event Date 10/06/2017

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), central regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tavr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to central regurgitation including malposition of the valve, impingement of a leaflet due to the guide wire, over inflation of the deployment balloon, post dilation of the implanted valve, and slow recovery of adequate ventricular flow post valve deployment and rapid pacing.All of these factors have the potential to contribute to suboptimal coaptation of the sapien valve leaflets and cause central aortic insufficiency.Occasionally there are cases where the root cause of the regurgitation cannot be determined.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.The patient screening manual instructs the operator on proper native valve leaflet assessment, taking into consideration the length, bulkiness and distribution of calcium on the native leaflets to determine whether valve performance will be impaired.During the manufacturing process, all sapien 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, it appears that the post dilation of the implanted s3 valve may have caused or contributed to the reported suboptimal coaptation of the leaflets and subsequent central leak.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 our (b)(4) affiliate, during a transfemoral tavr, post deployment the 26mm sapien 3 valve had severe aortic regurgitation and a 2nd s3 valve was implanted.The devices were prepped per manual.The procedure was uneventful and the s3 valve was deployed in a 70:30 aortic/ventricular position as intended.Post-deployment tee showed mild to moderate para- and transvalvular leak to 2-3 o¿clock direction.Post-dilation was performed and the delivery system was retrieved.Another tee showed that there was a ¿coaptation deficiency¿ between the non-coronary cusps and left coronary cusps, and a severe transvalvular aortic regurgitation.A second s3 valve was prepped and deployed with valve-in-valve soon.No ar was observed by the post-deployment tee and angiography, and the procedure was completed.

Manufacturer Narrative

Since the device and/or applicable photograph/video/imagery were not provided to edwards lifesciences for evaluation, the complaints of ¿leaflet inadequate coaptation ¿ in patient¿ and valve central leak were unable to be confirmed.During the manufacturing process, all sapien 3 valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction would contribute to the event.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 leaflet impingement in a highly calcified native valve (as reported, patient had a moderately calcified native valve and aortic root), impingement of a leaflet due to the guide wire, under expanded valve due to interference of calcification, leaflet damage due to post dilatation, 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 overcome with trouble shooting, which includes blood pressure recovery or support.The aforementioned patient and/or procedural factors can all contribute to suboptimal coaptation of the sapien 3 valve leaflets and cause central aortic insufficiency.The reported mild to moderate paravalvular leak observed post thv deployment indicated that the valve may have been under expanded.As the thv requires to be fully expanded for proper function, the under expanded valve may have restricted the motion of the leaflets and led to the reported abnormal coaptation, and central regurgitation.Also, the leaflet could have been impinged by calcium, in which case the motion of the leaflets could have been restricted, leading to the central regurgitation as reported in the complaint event.As reported, the central leakage worsened after post dilation, indicating that leaflet may have damaged and led to central leak.A definitive root cause was unable to be determined at this time.However, based on available information, patient factors (calcification) and procedural factors (leaflet damage due to post dilatation) may have contributed to the reported events.Review of the device history record (dhr), lot history, and manufacturing procedures did not provide any indication that manufacturing non-conformances contributed to the complaint event.No labeling/ifu/training inadequacies were identified.A review of the complaint history revealed that the occurrence rate did not exceed the october 2017 control limits for applicable trend categories.Therefore, no corrective or preventative action is 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: 6989509
• MDR Text Key: 90627098
• Report Number: 2015691-2017-03639
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2017

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: 08/19/2019
• Device Model Number: 9600TFX26J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2017
• Initial Date FDA Received: 10/30/2017
• Supplement Dates Manufacturer Received: 12/01/2017
• Supplement Dates FDA Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2017
• 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: 81 YR
• Patient Weight: 69