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	Insufficient Information (4580)
Date of Event	04/22/2025
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 a evoque procedure in tricuspid position where upon release of the evoque valve, the valve immediately canted towards ventricularly anterior and septal, with rocking motion.Safari wire across valve plane, and ds left in place to aid in valve stability.The ct surgeon was consulted, and a mid-sternotomy incision was made, on pump procedure, the evoque was removed, and ds/wire was guided out.The surgical valve was placed.When the surgeon was opening the chest, an adhesed lima graft was accidently severed.The chest was closed, and attempts to wean off the pump were made, without success.Ecmo was placed, and the patient was transferred to cvicu, and subsequently died shortly after.
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 analysis of images.The complaint for malposition - valve embolizes into ventricle was confirmed with objective evidence via imaging evaluation.Device history review (dhr) was completed and there were no non-conformances related to the issue observed and the device passed all manufacturing specifications.Available information suggests potential contributing factors to these findings include lack of leaflet capture, leaflet tethering, and high papillary muscle/chords.Imaging review revealed the shoulder of the evoque valve being slightly ventricular and therefore during atrial expansion the shoulder pressed up against the annulus instead of axially against it.Minor parallax was observed in flouro during valve expansion which can serve as an indicator for shifts to valve positioning during deployment.Malposition events such as embolization may be caused by a variety of factors such as device to native anatomy sizing (perimeter-derived diameter), use factors and procedural factors.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 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: 22020412
• Report Number: 2015691-2025-03815
• Device Sequence Number: 18512744
• Product Code: NPW
• UDI-Device Identifier: 00690103219074
• UDI-Public: (01)00690103219074(17)261118(11)241118
• 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: 2025
• Device Explanted 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 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: 04/22/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• 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: Death
• Patient Sex: Male