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

Model Number	9850EV48US
Medical Device Problem Codes	Malposition of Device (2616); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B2: other serious- even though there was no reintervention, there is a potential for reintervention in this case.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) using the evoque system.Initial delivery system positioning was too deep and required multiple unsuccessful maneuvers to improve height and trajectory.Imaging initially suggested adequate position for anchor deployment, but subsequent imaging revealed the system was deeper than anticipated.Attempts to gain additional height caused the outer capsule to retract without knob rotation, resulting in a slight atrial flip.Further retraction attempts met resistance, and after detaching the handle for tactile feedback, the catheter shifted approximately 3 cm toward the ventricle.Additional adjustments provided minimal improvement, and the valve was released in a non-ideal position, dropping anteriorly and posteriorly with anchor tips just above the tricuspid annulus plane.Post-release, severe central tricuspid regurgitation and moderate posterior paravalvular leak were noted.Contributing factors included insufficient device maneuvers to reach optimal position, imaging limitations, patient anatomy (functionally bicuspid tricuspid valve and rv lead), and suspected entanglement with subvalvular structures.The valve appeared stable post-release, no further intervention was planned at the time of discharge, and the patient was discharged in stable condition.
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: labelling review: the complaint for valve deployed too ventricular and central regurgitation was confirmed with empirical 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.Available information suggests that procedural issues (imaging issues, device maneuvers limited due to engagement with patient anatomy) contributed to the reported event.In addition, since the evoque valve malpositioned upon deployment, it affected proper evoque valve sealing on the annulus which subsequently can lead to central regurgitation through the evoque leaflets.Since no manufacturing non-conformances were found and no labeling, training, or ifu deficiencies were identified, no corrective or preventative 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 (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: cassandra cook ; 1 edwards way; irvine, CA 92614 ; 5743778277
• MDR Report Key: 23854983
• Report Number: 2015691-2025-10383
• Device Sequence Number: 10116912
• Product Code: NPW
• UDI-Device Identifier: 00690103217452
• UDI-Public: (01)00690103217452(17)270610(11)250610
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/29/2026

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: 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: 12/02/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/29/2026
• Date Device Manufactured: 06/10/2025
• 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: Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 59 KG