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

Model Number 9750TFX23A

Device Problems Fluid/Blood Leak (1250); Incomplete Coaptation (2507)

Patient Problem Cardiovascular Insufficiency (4445)

Event Date 02/22/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.Device remains implanted.

Event Description

As reported, post deployment of the 23mm sapien 3 ultra in the pulmonic position in a covered stent, there was major regurgitation noted on echocardiogram.They attempted to visualize the valve on transesophageal but could not acquire an angle that allowed them to see the leaflets of the s3 coapting.They chose to use an intracardiac echocardiogram catheter and could visualize the leaflets.The operator could see that one of the leaflets was not coapting and seemed to be stuck in the open position.The operators prepared another 23mm s3 ultra.It was deployed and appeared to be functioning well.The patient's hemodynamics improved.Additional information indicated that the access was transvenous.The patient has wide open aortic insufficiency in the pulmonic valve and pressures dropped.Once the operators implanted the second valve, the patient's pressures normalized.

Manufacturer Narrative

H6 updated the valve was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing, and dimensional analysis were unable to be completed.Review of complaint activities/attachments revealed no other information relevant to the complaints event.No imagery was provided to review.A device history record review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A review of the lot history revealed no other similar returned complaints for the trend categories.However, no manufacturing non-conformances were identified during the investigations of the similar complaints.The instructions were reviewed instruction for use (ifu) for commander delivery system with s3 thv, pulmonic and pulmonic procedural training manual and no ifu/training deficiencies were identified.Prior to delivery, the valve must remain hydrated at all times and cannot be exposed to solutions other than its shipping storage solution and sterile physiologic rinsing solution.Valve leaflets mishandled or damaged during any part of the procedure will require replacement of the valve.Place the thv completely within the landing zone.Avoid positioning the distal (outflow) half of the thv within any residual stenosis which may affect proper leaflet function.Use different fluoroscopic views, if uncertain about positioning.Placement of the thv in the proximity of stenosis can result in thv movement during deployment.Post-deployment thv assessment.Assess the valve post-deployment using fluoroscopy.Withdraw the delivery system from the valve before assessing.Perform post angiogram with wire still in lv to assess: valve position and expansion, patency of coronary arteries and functional assessment of valve (ar, pvl, etc.).Perform pressure assessment.Pulmonic valve replacement using the sapien 3 ultra (s3u) with the commander delivery system (ds) is not an indicated use at the time of implant.The risk management file captures risks for indicated device use only.The review of the risk management file is complete, and no further action is required at this time.Current risk mitigations include design and manufacturing controls, ifu warnings and cautions, and physician training on how to position and deploy thv.The benefits of the device outweigh the risks associated with malpositioned or under expanded thv resulting in additional percutaneous intervention the complaint for ''deployed valve exhibits central regurgitation'' and '' leaflet motion restricted'' was unable to be confirmed, a review of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of ifu/training manual revealed no inadequacies.It should be noted that it was a pulmonic case.The sapien 3 ultra thv (s3u) with the commander delivery system (ds) is currently indicated for a surgical or transcatheter bioprosthetic aortic valve, a surgical bioprosthetic mitral valve, or a native mitral valve with an annuloplasty ring replacement.It was off label for this case.During the manufacturing process, all sapien 3 ultra 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.For improper leaflet coaptation, there are multiple patient and procedural factors that alone or in combination can cause or contribute to a report of a restricted or non-functioning leaflet and central regurgitation including malposition of the valve, impingement of a leaflet due to the calcification, improper expansion, post-dilation of the implanted valve.All these factors have the potential to contribute to suboptimal coaptation of the sapien valve leaflets and cause central aortic insufficiency.As reported, ''the operator could see that one of the leaflets was not co-apting and seemed to be stuck in the "open" position''.Due to limited of information, a definitive root cause was unable to be determined at this time.For leaflet motion restricted, as reported, ''post deployment of the 23mm sapien 3 ultra in the pulmonic position in a covered stent, there was "major regurgitation" noted on echo''.In this case, one of the leaflets was not coaptating and stuck in the open position.It was likely the open leaflet led to central regurgitation.As such, available information suggests that procedural factors (leaflet motion restricted) may have contributed to the complaint event.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 13807943
• MDR Text Key: 287400920
• Report Number: 2015691-2022-04482
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201321
• UDI-Public: (01)00690103201321(17)230504
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2023
• Device Model Number: 9750TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female