MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM; PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES

Model Number	9850EV52US
Medical Device Problem Codes	Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing and a follow-up report will be submitted when the investigation is complete.
Event or Problem Description
Edwards received notification of an evoque valve in tricuspid position where, upon deployment, the valve shifted and required the placement of two sapien valve-in-valve deployments.Upon deployment, the evoque valve shifted more ventricular.Minutes after the release, the valve appeared to be rocking or unstable, with increased pvl on the septal side.The decision was made to perform a valve-in-valve procedure with a 29mm sapien.After the sapien deployment, there was a leak between the evoque and sapien sealing skirts.A second 29mm sapien valve was deployed.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6 and h11 additional h6 type of investigation codes: 'analysis of images' and 'labelling review' h6 investigation conclusion code: 'adverse event related to patient anatomy and/or condition' the complaint for malposition - valve embolizes into ventricle was confirmed with objective evidence.The imaging evaluation and screening review confirmed that the patient had a medical history of ebsteins anomaly with a danielson tricuspid valve repair.Ebsteins anomaly is a congenital heart malformation that occurs when the tricuspid valve of the heart does not form correctly and is severely apically displaced in the right ventricle.To correct this defect, this patient underwent the danielson tricuspid valve repair, which is a surgical procedure in which the native tricuspid valve is detached from the right ventricle, rotated, and reattached at the true atrioventricular junction.Due to this surgical correction, this patient present with two annuli - the 'native' annulus which the patient was born with, and the 'neo' annulus which is the surgically corrected annulus.As the patient had two annuli, the device anchors needed to be exposed at the level of the 'native' annulus, however, the device anchors needed to be at the level of the leaflet hinge points during ventricular expansion.Additionally, the evoque valve was sized for both annuli during screening.This challenging patient anatomy was noted to add to the confusion to the procedure by the clinical specialist present at this case.The imaging evaluation confirmed leaflet capture on each anchor during ventricular expansion.After final release, the evoque valve appeared unstable, and subsequently embolized into the right ventricle on all sides (anterior, posterior, septal, and lateral sides) of the valve.At the time of initial deployment, the valve did not fully expand within the anatomy.When the valve embolized into the ventricle, the inner and outer frames of the valve were able to fully expand.This is objective evidence that the surgical correction hindered the ability for the evoque valve to properly expand at the 'neo' annulus.After valve embolization, the patient had moderate transvalvular tricuspid regurgitation (tr) and moderate paravalvular leak (pvl).To increase valve stability and resolve the resulting tr and pvl, the decision was made to deploy a sapien valve for a valve-in-valve procedure.The sapien valve appeared to stabilize the evoque valve, however, the sapien valve was deployed too atrial so the patient had moderate transvalvular tr and severe pvl (between the sapien and evoque valve sealing skirts).A second sapien valve was deployed, which successfully sealed the leak between the evoque valve and the first sapien valve.The final result was trace transvalvular tr, and mild pvl, which was noted to be coming from the sutures of the surgical leaflet repair and not around the evoque or sapien valves.Available information suggests that patient conditions (ebsteins anomaly with the danielson repair) was the likely root cause of this event.Malposition events such as embolization may be caused by a variety of factors such as device to native anatomy sizing (perimeter-derived diameter), use factors and procedural factors.Based on the dhr review, there were no non-conformances related to the issue observed and the device passed all manufacturing specifications.Since no edwards defect was identified, corrective or preventative actions are not required.

• Brand Name: EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM
• Common Device Name: PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: cassandra cook ; 1 edwards way; irvine, CA 92614 ; 5743778277
• MDR Report Key: 21691778
• Report Number: 2015691-2025-02242
• Device Sequence Number: 21015406
• Product Code: NPW
• UDI-Device Identifier: 00690103217469
• UDI-Public: (01)00690103217469(17)260410(11)240410
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P230013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2026
• Device Model Number: 9850EV52US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female