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

Model Number	9850EV48US
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Edwards received notification of a transcatheter tricuspid valve replacement (ttvr) procedure involving the evoque system.Approximately 12 to18 hours post procedure, the patient was noted to have experienced a conduction disturbance.Post procedure that patient's heart rate was reported to generally be in the 40s.The patient was struggling and after ep evaluation a failure to thrive was noted.On postoperative day (pod) 2, the patient required placement of a permanent pacemaker due to heart block.The patient was reported to be in stable condition.The implant was deployed as intended in the tva.The patient's heart rate was noted to be in the 90s pre-procedure.
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing and a follow-up report will be submitted when the investigation is complete.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6, and h11.The complaint for "valve interacts with conduction system" was confirmed based on the information provided by the field clinical specialist.Based on the device history record (dhr) review, there were no non-conformances related to the issue observed and the device passed all manufacturing specifications.Available information suggests the valve interaction with the native conduction system likely contributed to the event.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.Such events are related to the patient's underlying condition.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.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 VALVE
• 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: 24690298
• Report Number: 2015691-2026-13515
• Device Sequence Number: 9977318
• Product Code: NPW
• UDI-Device Identifier: 00690103217452
• UDI-Public: (01)00690103217452(17)270903(11)250903
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 04/30/2026

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: 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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2025
• 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: Female
• Patient Weight: 117 KG