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

Model Number	9850EV44US
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Edwards was notified of a transcatheter tricuspid valve replacement (ttvr) using the evoque system.During the procedure, maneuvers were performed to release what appeared to be the anterior leaflet, later suspected to be a chordae.After valve release, the device canted anteriorly, causing minor paravalvular leak without central leak.A valve-in-valve procedure was performed using a sapien tavr, with the evoque valve held in place by a snare during deployment.The valve drop was unexpected and may have resulted from incomplete anterior leaflet capture, possibly involving a chordae.The patient remained stable and was preparing for discharge.
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing and a follow-up report will be submitted when the investigation is complete.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, and h11.Per internal imaging review, the perceived root cause of the valve being deployed too ventricular is procedural: lack of septal leaflet capture, sub-optimal depth at ventricular expansion, and interaction with subvalvular anatomy.The manufacturer's investigation is ongoing and a follow-up report will be submitted when the investigation is complete.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6, and h11.Additional type of investigation codes that were unable to be added in h6: analysis of images.Labelling review.The complaint for valve deployed too ventricular was confirmed with objective evidence based on imaging and procedural notes provided by the edwards field team.The device history record review was completed, and this device passed all manufacturing and sterilization inspections.No nonconformances related to the complaint event were identified.Valve settling events such as valve deployed too ventricular and valve deployed too atrial may be caused by a variety of factors such as minor subvalvular interaction that causes a drop immediately upon deployment.Additionally, these events may be caused by other procedural factors such as the inability to capture the leaflets or volume management.Since there are no confirmed product or labeling/ifu/training material non-conformances affecting distributed product and no other triggers have been met, no preventative or corrective actions are 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: 23857373
• Report Number: 2015691-2025-10392
• Device Sequence Number: 5030250
• Product Code: NPW
• UDI-Device Identifier: 00690103217445
• UDI-Public: (01)00690103217445(17)261201(11)241201
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 02/10/2026

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 Model Number: 9850EV44US
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 12/19/2025; 02/09/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/08/2026; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2024
• 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 Age: 87 YR
• Patient Sex: Female