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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
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 a transcatheter tricuspid valve replacement (ttvr) procedure involving the evoque system.Throughout the case, the trajectory remained posterior but approached near-coaxial alignment prior to deployment.Patient's saddle-shaped, non-planar annulus and a deep commissure anatomy presented significant constraints.Leaflet capture was confirmed on each anchor during the anchor spin, and leaflet pinning was not observed at any point in the procedure.The anchors were positioned at the hinge points of the annulus prior to final valve release.The valve expanded evenly and as expected during both ventricular and atrial expansion phases.However, following deployment, the posterior-lateral side of the valve dropped ventricularly.Due to canting, the valve did not achieve a complete seal, and as com paravalvular leak (pvl) was observed via color doppler flow.Volume optimization was appropriately managed on the day of the procedure.As per medical opinion, the perceived root cause of the event was anatomical.A snare was used to reposition and elevate the posterior-lateral side of the valve.There was no patient injury associated with this event, and the patient was reported to be 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: analysis of images.The complaint for valve deployed too ventricular was confirmed with objective evidence via imaging evaluation.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 a combination of patient factors, procedural factors, and image quality all contributed to the reported event.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.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2 and h11.Additional information stated that per internal imaging review, a potential root cause identified is procedure related: suboptimal position and trajectory, lack of leaflet capture and anatomical factors.The manufacturer's investigation is ongoing and a follow-up report will be submitted when the investigation is complete.

• 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: 23789809
• Report Number: 2015691-2025-09977
• Device Sequence Number: 10470035
• Product Code: NPW
• UDI-Device Identifier: 00690103217452
• UDI-Public: (01)00690103217452(17)270414(11)250414
• 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,Followup
• Report Date (Section B): 02/23/2026

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: 11/25/2025
• Supplement Date Received by Manufacturer: 01/22/2026; 02/19/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/10/2026; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2025
• 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 Age: 51 YR
• Patient Sex: Male