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

Model Number	9850EV48US
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/28/2025
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 procedure in tricuspid position where upon release the valve immediately dropped into the rv on all sides >10mm with anterior the deepest.Valve was stable with severe pvl cumulatively on all sides.Post deployment a decision was made to proceed with valve in valve with a 29mm s3ur device.
Additional Manufacturer Narrative
The complaint for malposition - valve embolizes into ventricle was confirmed with objective evidence via imaging evaluation and the call with the clinical specialists.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 patient factors (carcinoid disease, severe tethering, and significant septal plastering) contributed to the reported event.Specifically, carcinoid anatomy causes significant continuity of the leaflet, chordae tendineae, and papillary muscles, leaving minimal room between the thickened leaflet tip and papillary muscles for leaflet capture and final valve position.Additionally, this patient has significant septal plastering affecting 1/2 of the septal leaflet on the anterior (s-ant) and central (s-cent) portion.There was only 2.3-2.8mm between s-ant and the septal wall and 2.9mm between s-cent and the septal wall, making leaflet capture difficult in these regions (the evoque anchor is 4mm in diameter).There was also significant tethering (about 14mm) on all aspects of the tricuspid valve, which likely contributed to the evoque valve dropping post deployment.It was noted in the imaging evaluation that there was potential missed leaflet capture at the 2, 3 and 5 o'clock anchors.The anchors near 2 and 5 o'clock were in/near a commissure, and the 3 o'clock anchor was on the portion of the septal leaflet with significant septal plastering.Post deployment, anchors lost contact with the tricuspid valve annulus on all sides of the valve making it unlikely that missed leaflet capture was the main cause of the event.Therefore, the most likely cause of this event is due to patient factors (carcinoid disease, severe tethering, and significant septal plastering).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: 22169754
• Report Number: 2015691-2025-04688
• Device Sequence Number: 18455418
• Product Code: NPW
• UDI-Device Identifier: 00690103217452
• UDI-Public: (01)00690103217452(17)261023(11)241023
• 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): 07/16/2025

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: 05/28/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2024
• 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: Male