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

Model Number	9850EV56US
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	07/16/2025
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, during which it was confirmed that interaction between the valve and the right ventricular (rv) lead resulted in rv lead dislodgement.Approximately 4.5 hours post-procedure, the patient's existing pacemaker was no longer capturing, and their heart rate dropped into the 30s.A temporary pacemaker was placed at that time.On postoperative day (pod) 2, a new permanent pacemaker was successfully implanted.There was no reported patient injury, and the patient was reported to be in stable condition.It was noted that the rv lead had been adhered to the superior vena cava (svc), leaving minimal if any slack when crossing near the center of the septal leaflet.Rv dysfunction, which was mild prior to the implant, progressed to moderate post procedure.The procedure and valve deployment were otherwise routine.There were no concerns with the valve prior to deployment, and it was reported to have been deployed successfully with no issues.The patient's rhythm and hemodynamics remained stable throughout the procedure.
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: labelling review.The complaint for system interacts with previously implanted device (s) was confirmed with empirical evidence via information provided in the event description.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 evoque ifu contains warnings about device interactions with previously implanted devices, the lead was identified to have minimal slack prior to the procedure.Minimal lead slack has an increased probability of lead dislodgement due to any interaction with the lead being able to apply excessive tension and acutely pull on the contact point in the ventricle.Implanting the evoque valve has unavoidable interaction with the lead as it travels through the annulus of the valve and enough slack must be present for the evoque valve to shift the lead from the center of the valve to the annulus.Since no manufacturing non-conformances were found and no labeling, training, or ifu deficiencies were identified, 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: 22681346
• Report Number: 2015691-2025-06212
• Device Sequence Number: 21067271
• Product Code: NPW
• UDI-Device Identifier: 00690103219074
• UDI-Public: (01)00690103219074(17)261006(11)241006
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/11/2025

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: 9850EV56US
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2024
• 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
• Patient Weight: 72 KG