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

Model Number	9850EV48US
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	04/30/2025
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 procedure in tricuspid position where after successful device deployment the patient was pacing at a rate of 48bpm and during the case was in atrial fibrillation.The ra lead did appear fluoroscopically to be in contact with some of the locking tabs in the ra.The lead seemed to touch the evoque periodically during cardiac cycle.The physician was planning to interrogate the ra lead and check the thresholds and evaluate the need for a rv temporary balloon tipped pacing lead or potentially a cs lead if needed.The decision was later made that a micra would be implanted in a few weeks due to the interaction of the evoque with the ra lead.
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: labeling review the complaint for system interaction with previously implanted device(s) was confirmed with other empirical evidence.Based on the device history review (dhr), there were no non-conformances related to the issue observed and the device passed all manufacturing specifications.Potential contributing factors include mechanical interaction between the evoque valve in the tricuspid position and the retained ra pacing lead, which appeared to intermittently contact the valve during the cardiac cycle.This may have led to lead stress or altered pacing function.The rv lead was removed prior to implantation, possibly affecting ra lead positioning.There is no evidence of any evoque valve malfunction due to the interaction.A definite root cause is indeterminable.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: 22037955
• Report Number: 2015691-2025-03900
• Device Sequence Number: 8112622
• Product Code: NPW
• UDI-Device Identifier: 00690103217452
• UDI-Public: (01)00690103217452(17)260530(11)240530
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 07/08/2025

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: 05/30/2026
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2024
• 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