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	Insufficient Information (4580)
Date of Event	06/25/2025
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 transcatheter tricuspid valve replacement (ttvr) procedure involving the evoque system.After release, septal ant/septal side raised while post/lateral dropped.At least 2 septal anchors were above the annulus.Due to anchors being above the annulus on the septal side surgical intervention was the best option.The valve was removed and a surgical valve was implanted.There was moderate pvl regurgitation on septal side.During the procedure and leading up to the valve deployment, leaflets were captured and at appropriate height.Leaflet capture was confirmed on each anchor during the anchor spin.The anchors were at the hinge points of the annulus prior to final valve release.The valve did expand evenly and as expected during ventricular and atrial expansion stages.There was appropriate volume optimization the day of the procedure.The pressure was noted to start dropping which sped up rest of deployment.It was observed that post valve tilting, the nosecone may have gotten caught in between 2 locking tabs.Kept counter clocking until the nosecone came off and then the nosecone was able to be removed.An internal imaging review showed that the 52mm evoque valve embolized into the right ventricle acutely after deployment.The septal-anterior side was positioned >10 mm ventricular and the lateral-posterior side >10 mm atrial to the annulus, resulting in most of the anchors losing contact with the annulus.The valve appeared unstable, with trace transvalvular tricuspid regurgitation and moderate paravalvular leak.The primary root cause identified was patient-related, specifically papillary muscle height.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, and h11.Additional information: an internal imaging review showed that the 52mm evoque valve embolized into the right ventricle acutely after deployment.The lateral-posterior side was positioned >10 mm ventricular and the septal-anterior side >10 mm atrial to the annulus, resulting in most of the anchors losing contact with the annulus.The valve appeared unstable, with trace transvalvular tricuspid regurgitation and moderate paravalvular leak.The primary root cause identified was patient-related, specifically papillary muscle height.The manufacturer's investigation is ongoing and a follow-up report will be submitted when the investigation is complete.
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: analysis of images.The complaint for "malposition - valve embolized into the ventricle" was confirmed based on imaging evaluation.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 a combination of anatomical features along with procedural steps may have likely contributed to the event.A potential contributing factor to the event may have been the papillary muscle height inhibiting the valve or potentially misleading echo evaluation of the hinge point.Since no manufacturing non-conformances were confirmed and no ifu/training deficiencies were identified, no corrective/preventative actions are required.
Additional Manufacturer Narrative
Additional information received via journal article reported that once patient was taken to the operating room peripheral cardiopulmonary bypass was established, followed by redo sternotomy and bicaval cannulation.Beating-heart right atriotomy was performed and the maldeployed valve was removed using sequential rotational anchor release.Native valve inspection revealed leaflet injury, and tricuspid valve replacement with a 33-mm bioprosthesis was performed.The patient had an uncomplicated recovery and was discharged home on postoperative day 8.

• 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: 22537784
• Report Number: 2015691-2025-05837
• Device Sequence Number: 15309841
• Product Code: NPW
• UDI-Device Identifier: 00690103217469
• UDI-Public: (01)00690103217469(17)261009(11)241009
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/01/2026

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: 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: 06/25/2025
• Supplement Date Received by Manufacturer: 07/23/2025; 09/22/2025; 04/27/2026
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/07/2025; 09/22/2025; 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2024
• 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
• Patient Weight: 79 KG