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

Model Number	9850EV48US
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2025
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 a transcatheter tricuspid valve replacement (ttvr) procedure involving the evoque system, during which heavy annular calcium interfered with anchor positioning.Upon final release, the valve shifted ventricular.The evoque valve was stabilized using a snare inserted via the femoral approach.Due to moderate paravalvular leak (pvl), a 29mm sapien valve was implanted within the evoque valve, aligning its sealing skirt with the evoque locking tabs to minimize pvl.Final result was trace tricuspid regurgitation.The patient had severe tricuspid stenosis with leaflet calcification, and pre-dilation with a 28mm balloon was performed to improve orifice size.Despite initial challenges with calcium interaction, the procedure concluded with satisfactory hemodynamic outcome.It is suspected that heavy annular calcium contributed to suboptimal anchor engagement and valve shift during deployment.
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.Labeling review.Based on the complaint investigation, the complaint for valve deployed too ventricular was confirmed with objective evidence.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.A review of the screening information demonstrated that the patient anatomy was highly complex due to severe tricuspid calcification and moderate stenosis.The patient's tricuspid valve morphology was a stenotic tri-leaflet valve with significant leaflet calcification extending to the chords.The imaging evaluation demonstrated that the valve was compressed by the patient's calcification of the tricuspid valve.The patient's calcification prevented the valve from deploying at the correct height within the annulus and led to the valve being deployed too ventricular with the locking tabs of the valve observed to be at the level of the annular plane.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.Typically, these events do not require interventions.The screening process verifies papillary muscle locations for events such as these if diastolic oversizing is not ideal.No preventative or corrective actions are required because there are no confirmed product or labeling/ifu/training material non-conformances affecting distributed product and no other triggers have been met.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6, and h11.Upon review of additional information received, this mdr is linked/related to mfr report number 2015691-2025-09603 on complaint number (b)(4).Due to (b)(4) with mfr report number 2015691-2025-09603 being a duplicate of this complaint, that complaint and mdr will be voided, and this mdr will remain.Based on the complaint investigation, the complaint for valve deployed too ventricular was confirmed with objective evidence.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.Additional information was received through article about the patient medical history.The patient was an 87-year-old male with chronic obstructive pulmonary disease (copd), chronic kidney issues, heavy smoking history, and nyha class iii symptoms.The article calls out the guidance of intracardiac echocardiography (ice) and demonstrates the compression on the evoque valve frame with the postero-septal part of the frame falling down.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.Typically, these events do not require interventions.The screening process verifies papillary muscle locations for events such as these if diastolic oversizing is not ideal.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 were 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 Contact: cassandra cook ; 1 edwards way; irvine, CA 92614 ; 5743778277
• MDR Report Key: 22388902
• Report Number: 2015691-2025-05398
• Device Sequence Number: 20577776
• Product Code: NPW
• UDI-Device Identifier: 00690103217452
• UDI-Public: (01)00690103217452(17)270106(11)250106
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/05/2025

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 Model Number: 9850EV48US
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 08/06/2025; 12/02/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/12/2025; 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2025
• 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: Male