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

Model Number	9850EV48US
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Arrhythmia (1721)
Type of Reportable Event	Serious Injury
Event or Problem Description
Edwards received notification of an evoque in tricuspid position where a patient needed a pacemaker post implant but had a great procedural result.The physician said that the morning following implant, the echo showed a perfect working evoque valve for the patient with no remarkable findings.It was attempted to cross the valve and implant a single pacemaker lead for rhythm management.This case was aborted for reasons that were unknown, but was before a lead was placed in the rv as planned.The physicians in that case claim they had no interaction with the valve the patient has remained stable throughout, while the valve by tee & tte looked to be performing normally.The physician and the cardiovascular team decided to take a management device approach avoiding placing anything in the right ventricle.The physician stated that the patient was doing fine.
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Event or Problem Description
Additional information received stated that the patient had pre-existing history of atrial fibrillation, so it was a known possibility post implantation of evoque device.The patient final outcome is stable.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, b5, b7, g3, g6, h2 and h11.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b2, b4, b5, g3, g6, h1, h2, h6 and h11.
Event or Problem Description
Per additional information received, the patient passed away.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b2, b4, b5, g3, g6, h1, h2, h6 and h11.Additional h6 type of investigation codes: analysis of images and 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.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 extensive medical history per physician team.Pod 1 following evoque implantation the patient developed a conduction disturbance.The team attempted to implant a ppm on pod 7 but had to abort due to external issues.Patient passed away approximately 1 month following implantation, however per physician the cause of death was not related to the evoque valve.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 - in extreme conditions death.Imaging unable to identify rhythm disturbance or a root cause of disturbance.A definitive root cause is unable to be established at this time.
Event or Problem Description
Per additional information the physician expressed that the passing was related to severe medical issues.He said that the team does not think that the patient passing is related to the evoque valve, but the patient had a complicated medical history and the course of treatment, which included multiple procedures and cardiac rehabilitation was her last hope but too much for her body in the end.He described it as a passing related to medical issues that even the best science and medicine could not ultimately help.

• 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: 21752736
• Report Number: 2015691-2025-02513
• Device Sequence Number: 9748963
• Product Code: NPW
• UDI-Device Identifier: 00690103217452
• UDI-Public: (01)00690103217452(17)261119(11)241119
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Followup,Followup
• Report Date (Section B): 06/17/2025

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: 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: 03/07/2025
• Supplement Date Received by Manufacturer: 04/02/2025; 05/07/2025; 06/13/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 04/28/2025; 06/02/2025; 06/17/2025
• Date Device Manufactured: 11/19/2024
• 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: Death; Required Intervention
• Patient Sex: Female