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

Model Number	9850EV52US
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	02/26/2025
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 valve in tricuspid position where pre-procedure, patient had a-fib with a bundle branch block (bbb) and a small shallow rv.During wire placement, the patient experienced arrhythmias.Post implantation, patient developed bradycardia and a permanent pacemaker was implanted.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6 and h11 h6 additional code for type of investigation: labelling review the complaint for valve interacts with conduction system was confirmed with other empirical evidence via information provided by edwards clinical specialist.The reported conduction disturbance does not allege a malfunction that could be related to an edwards manufacturing deficiency.Event may have potentially been influenced by patient health factors, however, a definite root cause is unable to be determined.The device history record review was completed, and this device passed all manufacturing and sterilization inspections.No non-conformances related to the complaint event were identified.Since no edwards defect was identified, corrective or preventative actions are not required.Information provided per the instructions for use (ifu), conduction system disturbance and/or heart block which may require treatment (including permanent pacemaker) are potential adverse events.Heart block and other conduction disturbances are common in patients with underlying cardiovascular disease and can be exacerbated or aggravated with standard intra-operative medications or anesthesia.Patient was reported to have atrial fibrillation with a bundle branch block (bbb) and a small shallow rv prior to the procedure.During wire placement, the patient experienced arrhythmias.Post evoque implantation, patient developed bradycardia and a permanent pacemaker (ppm) was implanted.Other mechanisms for conduction abnormalities could be related to coronary obstruction due to air embolism, coronary spasm and/or local edema affecting the av node.Conduction disturbances have also been documented during transcatheter cardiac procedures as a result of direct interaction with cardiac anatomy, especially in patients with underlying conduction abnormalities.Other potential causes include trauma by a guidewire or delivery system.Additionally, cardiac conduction system complications are known risks with tricuspid valve interventions due to the proximity of the atrioventricular node (av node) to the septal leaflet of the tricuspid valve.These conduction disturbances can lead to post-operative heart block requiring pacemaker implantation.No imaging was provided for this investigation.A definitive root cause is unable to be established at this time.

• 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: 21654927
• Report Number: 2015691-2025-02107
• Device Sequence Number: 7480398
• Product Code: NPW
• UDI-Device Identifier: 00690103217469
• UDI-Public: (01)00690103217469(17)260715(11)240715
• Combination Product (Y/N): N
• 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): 04/28/2025

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: 07/15/2026
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2024
• 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