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 02/05/2018

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is ongoing.

Event Description

As reported by our (b)(4) affiliate, after post-dilation with additional volume the 23mm sapien 3 valve had moderate central leak and a valve-in-valve procedure was performed.At the beginning of the procedure, the right coronary artery was protected due to low height of 7.9mm.A 23mm sapien 3 valve was deployed without problem in a 70:30 aortic/ventricular position.Post-deployment, echo showed mild paravalvular leak (pvl) and post-dilation was performed with an additional 1ml contrast solution added to the nominal volume.After post-dilation, moderate central leak was observed from the right coronary cusp ¿ left coronary cusp.The echo showed a motion abnormality in the leaflets.A new 23mm s3 valve was implanted in the first valve.The procedure was completed after confirming the final pvl was trivial.  a guiding catheter had been inserted through the s3 valve's stent for coronary angiography post valve deployment.At that time, the physician felt some resistance.At the end of the procedure, the physician speculated that the valve leaflet might have been damaged while manipulating the guiding catheter post deployment of the first valve.However, it was unclear whether the resistance was a cause of the event.

Manufacturer Narrative

No photograph, video or imagery was returned for evaluation.A device history review (dhr) was performed and did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.A lot history review revealed no other similar complaints related to ¿leaflet ¿ motion restricted ¿ in patient¿, ¿leaflet ¿ inadequate coaptation-in patient¿, or ¿valve ¿regurgitation-central leak¿.A review of complaint history revealed that the occurrence rates did not exceed the february 2018 control limits for applicable trend categories ¿leaflet motion restricted (in patient)¿ and ¿regurgitation¿.No instructions for use (ifu) or training deficiencies were identified.Manufacturing inspections support that it is unlikely that a manufacturing nonconformance contributed to the reported complaint.Due to the device and/or relevant imagery/video not being returned for evaluation, the complaints of ¿leaflet ¿ motion restricted-in patient¿ and ¿valve ¿ regurgitation-central leak were unable to be confirmed.A review of the dhr, 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 impaired.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/damage by a guidewire/diagnostic catheter, leaflet impingement in a calcified valve, leaflet damage due to overexpansion with extra volume during 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 be overcome with troubleshooting, 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 regurgitation.Given the measurement of annulus area (387mm2) and level of calcification (severe at ncc), it appears that a correct valve size (23mm) was selected.As reported, the valve was deployed successfully and landed at targeted location with 70/30 a/v ratio.Post deployment, echo showed mild pvl, and therefore post dilatation was performed with the extra 1ml volume.It was after post dilatation that a moderate central leak was observed.Per ifu, the thv is required to be deployed with prescribed volume for proper function.Overinflating a valve with extra 1ml could damage the leaflets, which could restrict the motion of the leaflets and lead to the reported abnormal coaptation and central regurgitation.Additionally, it was reported that a guiding catheter was inserted through the valve¿s stent for coronary angiography after initial thv deployment.Therefore, it is possible that the leaflets were impinged by a diagnostic catheter, affecting the mobility of the leaflets and resulting in central leak.As the patient had a severely calcified ncc, it is also possible that the leaflet was impinged by calcium, in which case the motion of the leaflet could have been restricted, leading to the same failure mode.However, without the procedural imagery, the suggested root causes above could not be confirmed.There is insufficient information to determine an exact root cause at this time.A review of edwards lifesciences risk management documentation was performed for this case.  the reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.  due to the device and/or relevant imagery/video not being returned for evaluation, the complaints of ¿leaflet ¿ motion restricted-in patient¿ and ¿valve ¿ regurgitation-central leak were unable to be confirmed.No manufacturing non-conformance's were identified during evaluation.There is insufficient information to determine the definitive root cause at this time, but based on given information, procedural factors (leaflet damaged due to overexpansion with extra volume during post dilatation, leaflet impinged by diagnostic catheter/calcification) may have contributed to the reported event.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: 7312278
• MDR Text Key: 101461908
• Report Number: 2015691-2018-00759
• 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: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2019
• Device Model Number: 9600TFX23J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR