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	Foreign Body Embolism (4439)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Edwards received notification of an evoque procedure in tricuspid position where upon release the valved canted, however per device proctor and echo proctor there was no malposition.The echo on pod 1 shows device in the same position with no migration and mild pvl.The valve appeared stable still on pod 2.There was no migration noted per physicians, but still mild tr.The patient was discharged home in stable condition with mild central and pvl, and tr.An internal imaging review confirmed that the evoque valve embolized into the right ventricle, acutely after device deployment.The anterior, septal, and lateral sides of the evoque valve are in the right ventricle, resulting in most of the anchors losing contact with the annulus.The evoque valve appears minorly unstable.The final transvalvular tr is mild and the final pvl is qualitatively mild to moderate.
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.A follow-up report will be submitted when the manufacturer's investigation is complete.
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 malposition: valve embolizes into ventricle 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.The imaging evaluation confirmed that during ventricular expansion, lack of leaflet capture was observed on two consecutive anchors (2 o'clock and 4 o'clock).At initial release, the valve was at the incorrect depth with the anterior and septal sides too ventricular from the annulus (>10 mm from the annulus).Upon deployment, the anterior, septal, and lateral sides of valve are >10 mm from the annulus and most of the anchors lost contact with the annulus.Available information suggests procedural factors (lack of leaflet capture on two consecutive anchors and incorrect depth) contributed to the event.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.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: 22160329
• Report Number: 2015691-2025-04625
• Device Sequence Number: 8678815
• Product Code: NPW
• UDI-Device Identifier: 00690103217452
• UDI-Public: (01)00690103217452(17)260729(11)240729
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/29/2025

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 Expiration Date: 07/29/2026
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2024
• 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: Other
• Patient Sex: Male