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

Model Number	9850EV56
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Edwards received notification of an evoque procedure in tricuspid position where a temporary pacemaker was placed post procedure due to new onset heart block.
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
Additional information was received that the patient had a right bundle branch block (rbbb) at baseline and was deemed high risk for ppm.And the root cause of the event was deployment of the evoque valve in the annulus knocking out the already fragile conduction system.Also, it was noted that the heart block worsened post procedure, and on an unspecified day post procedure a ppm was implanted.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6 and h11.Based on the complaint investigation, the complaint for valve interacts with conduction system was confirmed with emperical evidence via information reported by edwards clinical specialist.As reported, the patient experienced a new onset heart block after the procedure and a pacemaker was placed.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.Patient factors that have been noted are pre-existing arrhythmias/conduction disturbances (such as bradycardia during anesthesia).Patient factors that could contribute are pre-existing factors such as pre-existing conduction disturbances and patients with previous heart transplants.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 are 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: 22137009
• Report Number: 2015691-2025-04389
• Device Sequence Number: 15296899
• Product Code: NPW
• UDI-Device Identifier: 00690103219074
• UDI-Public: (01)00690103219074(17)260604(11)240604
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 07/24/2025

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: 06/04/2026
• Device Model Number: 9850EV56
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 06/04/2025; 07/18/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/09/2025; 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2024
• 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