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

Model Number	9850EV44US
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	06/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Edwards received notification of a transcatheter tricuspid valve replacement (ttvr) procedure involving the evoque system, which was complicated by right ventricular (rv) perforation, valve embolization, and the need for surgical intervention including bioprosthetic valve replacement and permanent pacemaker (ppm) placement.During the procedure, after reaching full white knob, the patient experienced a drop in blood pressure.Imaging revealed a pericardial effusion, and pericardiocentesis was performed to relieve tamponade.The valve was then quickly deployed while the patient's rv exhibited akinesis with absent contractile function.At this time, the effusion reaccumulated, requiring additional drainage.During catheter withdrawal, the evoque valve embolized into the ventricle.Emergency surgery was initiated.The patient was placed on ecmo, stabilized, and transferred to the operating room, where an rv apical perforation was repaired.The embolized evoque valve was removed, and a surgical bioprosthetic valve was implanted.A permanent pacemaker (ppm) was also placed.A pigtail catheter was initially used for wire placement at the rv apex, but wire position was lost during manipulation.Multiple maneuvers were required to reposition the wire, as the initial trajectory was too ventricular.The wire was successfully repositioned mid-ventricle, above the moderator band, in an anterolateral orientation, allowing for appropriate device height.Leaflet capture was confirmed, and the valve was deployed while the patient was hemodynamically unstable.Despite this, leaflet mobility and rv function were preserved.Additional information received from the fcs indicated that conduction system disruption is a known risk during surgical tricuspid valve replacement and may necessitate permanent pacemaker (ppm) placement.Confirmation of this specific case detail is pending follow-up with the clinical team.
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing and a follow-up report will be submitted when the investigation is complete.This is one of two manufacturer reports being submitted for the same event.Reference related manufacturer report #(b)(4).
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: labeling review.Based on the complaint investigation, the complaint for malposition - valve embolizes into ventricle 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 factors (rv perforation, expedited valve deployment) contributed to the event, however imaging was not provided for review.Therefore, a root cause cannot be determined.Malposition events such as embolization may be caused by a variety of factors such as device to native anatomy sizing (perimeter-derived diameter), use factors and procedural factors.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.This is one of two manufacturer reports being submitted for the same event.Reference related manufacturer report 2015691 2025 05912.

• 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: 22559601
• Report Number: 2015691-2025-05913
• Device Sequence Number: 9457548
• Product Code: NPW
• UDI-Device Identifier: 00690103217445
• UDI-Public: (01)00690103217445(17)261104(11)241104
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P230013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 08/20/2025

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: 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: 06/30/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2024
• 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: Female