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

Model Number 9755RSL29A

Device Problems Perivalvular Leak (1457); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 10/19/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.Valve remains implanted.

Event Description

During a valve in mac, after mitraclip on a patient, the operators placed the first 29mm sapien 3 ultra resilia valve slightly too atrial and had mitral regurgitation as the result.They placed a second 29mm sapien 3 ultra resiilia valve inside of the first valve and fixed the paravalvular leak.The patient is successfully recovering.

Event Description

Per medical records review, the patient had emergent surgery for severe mitral regurgitation and moderate to severe mitral stenosis.Due to a very large mitral valve annulus, a non-ew mitraclip device was placed as a lateral anchor, at which point a 29mm s3ur valve was implanted in the mitral position.However, it was too atrial and there was a significant posterior paravalvular leak.The decision was made to implant a second 29mm s3ur as a valve-in-valve (viv) inside the first tmvr.The second tmvr was implanted successfully, and there was only trace perivalvular leak, which was "much, much improved." it would appear that the first tmvr which landed too atrial, was likely due to the patient's very large mitral annulus which required the use of a non-ew mitraclip placed laterally and used as an anchor for the subsequent tmvr placement.There was no indication in the op note that there was any central regurgitation after either of the 29mm s3ur valves were deployed in the mitral position.There was only a significant paravalvular regurgitation/leak that was rectified by a viv deployment of the 29mm s3ur valve.With the final outcome of trace perivalvular leak.

Manufacturer Narrative

The 29mm sapien 3 ultra resliia valve was not returned for evaluation.Without the device returned for evaluation, visual inspection, functional testing, and dimensional analysis were unable to be completed.The following instructions for use (ifu) were reviewed: commander delivery system with s3/s3u/s3ur.Based on this review, no ifu/training deficiencies were identified.It should be noted that the thv was deployed in the native mitral position with severe mitral annular calcification (mac) and mitraclip (clip-like device used in mitral valve repairs).The sapien 3 ultra resilia (s3ur) thv with the commander delivery system (ds) is currently only indicated for valve replacement involving a native aortic valve, surgical or transcatheter bioprosthetic aortic valve, surgical bioprosthetic mitral valve or a native mitral valve with an annuloplasty ring.Therefore, this was an off-label operation.The ifu and training manuals in this section are for tf (transfemoral) procedure in the aortic/mitral position and were reviewed for relevant guidance for an s3ur implant using a commander delivery system.The complaints for a malpositioned valve and paravalvular leak were confirmed based on the medical records received.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of ifu/training materials revealed no deficiencies.It should be noted that the thv was implanted in native mitral position with severe mitral annular calcification (mac) and mitraclip (clip-like device used in mitral valve repairs), which is not an indicated use of the device.Therefore, this was an off-label operation.As reported, "during a valve in mac after mitraclip on a patient.The operators placed the first 29s3ur slightly too atrial and had mitral regurgitation as the result.They placed a second 29s3ur inside of the first valve and fixed the paravalvular leak.The patient is successfully recovering." in this case, the valve was implanted in an off-label procedure, which could have an impact on the thv positioning and deployment technique/considerations resulting in the valve landing too atrial.As the valve was deployed too atrial, it is likely that the thv skirt was unable to be properly sealed against the annulus leading to paravalvular leak (pvl).In addition, the presence of severe annular calcification could have contributed to the formation of pvl channels due to irregular contact rendered between the valve and the target site.Available information suggests that procedural factors (malpositioned thv, valve positioning, and deployment technique/off-label operation) and/or patient factors (calcification) may have contributed to the complaint event.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

• Brand Name: EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, 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: 15781500
• MDR Text Key: 303559632
• Report Number: 2015691-2022-09204
• Device Sequence Number: 1
• Product Code: NPU
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9755RSL29A
• Device Catalogue Number: 9755RSL29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• 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: 74 YR
• Patient Sex: Female