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

Model Number	9850EV52US
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
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 the patient was screened for a 52 mm evoque with annular oversizing of 14.8%/20.9% and basal oversizing of -15.5%/-2%; screening noted a septal flail.Unremarkable procedure through deployment, all anchors confirmed to capture leaflets minus the area of the septal leaflet that was flail and the commissures.Anterior septal side of the device dropped post deployment.Snares were applied from both internal jugular and femoral approach to stabilize the valve position.A 29mm sapien (s3) was implanted in the evoque valve; snares were removed post sapien deployment, valve stayed in place and is stable with a remainder trace pvl in the posterior septal location of where the flail was located.Per internal imaging evaluation, it was confirmed that the 52mm evoque valve embolized into the right ventricle requiring one sapien valve.
Additional Manufacturer Narrative
Additional type of investigation codes that were unable to be added in h6: labeling review analysis of images.The complaint for valve embolizes into ventricle was confirmed with objective evidence via the imaging evaluation.This patient had a septal flail/prolapse affecting more than half of the septal leaflet in screening.Additionally, there was a pacing lead that was expected to interact with evoque, so the site removed the icd lead prior to evoque deployment.Per the call with the clinical specialists, it was identified that the lead extraction caused an additional flail on the posterior-septal portion of the valve.The flail extended from posterior-septal commissure to the anterior-septal commissure, causing approximately 4 anchors to not have adequate leaflet capture.Therefore, available information suggests that the flail circumference increased so there was not enough leaflet engagement for valve retention.It was also identified in the imaging evaluation that the 6 o'clock anchor was low at atrial expansion, which also could have contributed to lack of annular retention.This patient also had negative basal oversizing, therefore there was minimal retention in the rv, contributing to valve embolization.The device history record review was completed, and this device passed all manufacturing and sterilization inspections.No nonconformances related to the complaint event were identified.Since no manufacturing non-conformances were confirmed and no ifu/training deficiencies were identified, no corrective/preventative 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: 22098307
• Report Number: 2015691-2025-04193
• Device Sequence Number: 8408568
• Product Code: NPW
• UDI-Device Identifier: 00690103217469
• UDI-Public: (01)00690103217469(17)260708(11)240708
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/18/2025

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: 07/08/2026
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2024
• 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