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

Model Number 9600TFX23J

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Aortic Regurgitation (1716)

Event Date 02/02/2018

Event Type  Injury  

Manufacturer Narrative

The device is not available for return, as it remains implanted in the patient.Investigation of this event is ongoing.

Event Description

As reported by our (b)(4) affiliate, post deployment the 23mm sapien 3 valve had central leak and a valve-in-valve procedure was performed.A 23mm sapien 3 valve was deployed uneventfully with 1ml less than nominal volume.  the valve was implanted at the intended position.Post-deployment tee showed more than mild aortic regurgitation (ar) and post-dilation was performed with the same volume.The paravalvular leak (pvl) disappeared, but the central leak remained.The safari wire was retracted from the left ventricle (lv), but there was no change on the mild central leak.  echo long axis image showed that a part of the leaflets was not working.¿when the physician pushed the leaflet with the pigtail catheter, it was able to be inserted into the lv without resistance; it indicated that the valve did not function." another 23mm sapien 3 valve was prepped and a valve-in-valve was performed.Post-deployment tee showed no ar and the procedure was completed.The physician commented that the cause of the ar was unknown; it might be a malfunction of the valve.

Manufacturer Narrative

Additional information: due to the device and/or relevant intra-procedural imagery/video not being returned for evaluation, the complaints of motion restricted leaflet and central leak were unable to be confirmed.A review of the device history records, lot history, and complaint history revealed no indication that a manufacturing non-conformance contributed to the complaint.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 contributed to the event.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 whether valve performance will be implanted.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 by a guidewire, thv being deployed too ventricular, leaflet impingement in a calcified valve, under expanded valve due to improper volume used for deployment, under expanded valve due to interference of calcification, 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.Per the ifu, central regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tavr) procedure.  the aforementioned patient and/or procedural factors can all contribute to suboptimal coaptation of the sapien 3 valve leaflets and cause central aortic insufficiency.In this case, based on the patient¿s aortic valve area (407 sq.Mm), diameter (20.6 mm), and severe bulky calcification, it appears that a correct valve size (23mm) was selected.As reported, the valve was initially deployed with 1ml less than nominal volume and landed at targeted location with 80:20 aortic/ventricular.Post deployment, tee showed more than mild aortic regurgitation, and therefore post dilatation was performed with the same volume.After post-dilatation, the pvl leak disappeared, but the central leak remained even after the removal of the guidewire from the left ventricle.The physician also tried to manipulate the leaflet with the pigtail catheter, but was not successful.This indicates that the reported central leak as a result of leaflet impingement by a guidewire/diagnostic catheter or thv being deployed too ventricular is unlikely.Per training manual, the thv is required to be fully expanded for proper function.Deploying a valve with 1ml less could cause the valve to be under expanded, which could restrict the motion of the leaflets and lead to the reported abnormal coaptation and central regurgitation.Additionally, the patient had a severely calcified native aortic valve.As such, it is possible that the leaflet was impinged by calcium, in which case the motion of the leaflet could have been restricted, leading to the central regurgitation as reported in the complaint event.However, without the procedural imagery and/or post procedural ct scan, the level of expansion of the deployed valve could not be assessed.As a result, the suggested root causes above (under expanded valve and leaflet impingement by calcification) could not be confirmed.No manufacturing non-conformances were identified during this investigation.There is insufficient information to determine the definitive root cause at this time.Since no labeling or ifu/training inadequacies were identified and review of the complaint history revealed that the occurrence rate did not exceed the february 2018 control limits for applicable trend categories, 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
• MDR Report Key: 7301820
• MDR Text Key: 101116558
• Report Number: 2015691-2018-00668
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2019
• Device Model Number: 9600TFX23J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Weight: 37