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

Model Number	9850EV52US
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Foreign Body Embolism (4439); Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following sections were updated/corrected/added: d6b.Explant date is unknown.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.There was no indication of active infection or endocarditis before the procedure.However, the patient had endocarditis years ago and it was known.As a result, the clin dev was contacted to make sure there was enough anterior leaflet to grab.It was confirmed that there was full leaflet capture.Post implant the valve appeared to be seated appropriately with no leak.However, the valve was lower 24 hours post deployment.Upon review, it appears septal and posterior anchors were low upon deployment ~17-20 from hinge points) which led to the valve canted post procedure as there was only annular os for this patient.It was also reported that the patient was up 30 kg, however, the measurements were still within limits for the 52 mm valve.There was no patient injury due to this event.The patient went to surgery to replace the valve at an unknown date post procedure.The patient passed after multiple organ failure post op.
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 malposition - valve embolizes into ventricle 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.The imaging review confirmed the malposition and additionally noted significant rocking motion as well as moderate-severe pvl.Suboptimal depth, severe leaflet tethering, and/or large coaptation gap are potential contributing factors, as they can make leaflet capture more difficult.However, whether the root cause is patient-related or procedural related cannot be determined based on available information.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 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: 24148153
• Report Number: 2015691-2026-10518
• Device Sequence Number: 8887869
• Product Code: NPW
• UDI-Device Identifier: 00690103217469
• UDI-Public: (01)00690103217469(17)270407(11)250407
• 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: 2026
• 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): 02/10/2026

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: 9850EV52US
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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 Sex: Male
• Patient Weight: 122 KG