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

Model Number	9850EV56US
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
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 anterior leaflet was tethered at 19mm and that is thought to be the cause of the initial drop after deployment.The valve dropped even more after wire manipulation when the curl appeared to get wrapped in the drop loop.The physician placed pigtail and yanked on the wire, valve dropped significantly.Because the valve canted, a snare had to be used and it was necessary to do a valve in valve.During the anchor spin, leaflet capture was confirmed on all anchors, no major issues getting under the anterior tethered leaflet.Minimal pvl observed.Most of the anchors lost contact with the annulus, it was thought that the valve was held in place by the anterior papillary muscle.The decision was then made to do valve in valve.Sapien deployed at correct height within evoque valve and there was no leak between valves.The patient is reported to be doing well.
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.Based on the complaint investigation, the complaint for malposition - valve migrates from deployment position was confirmed with empirical evidence.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.Available information suggests that procedural factors (forceful wire removal) and anatomical factors (severe leaflet tethering and negative basal rv oversizing) contributed to the event, however, no objective evidence was provided for review.Therefore, a root cause could not be determined.Malposition events such as migration may be caused by a variety of factors such as device to native anatomy sizing (perimeter-derived diameter), procedural factors and patient factors.Migration may occur as a result of lack of leaflet capture and rv volume changes upon implantation or volume management.The mismanagement of rv volume may result in valve instability and may cascade to valve migration.No preventative or corrective actions are required because there are no confirmed product or labeling/ifu/training material non-conformances affecting distributed product and no other triggers have been met.

• 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: 22322404
• Report Number: 2015691-2025-05151
• Device Sequence Number: 21088461
• Product Code: NPW
• UDI-Device Identifier: 00690103219074
• UDI-Public: (01)00690103219074(17)270203(11)250203
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/04/2025

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: 9850EV56US
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2025
• 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: Male