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

Model Number	9850EV52US
Medical Device Problem Codes	Migration (4003); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
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 where prior to deployment the evoque anchors were at hinge points of annulus, and on release the valve shifted down on the anterior side underneath the 2 intact teer devices (pascal ~4 years old).Post evoque valve deployment there was severe with mild pvl at the clips and the inner frame of the evoque valve became slightly oval instead of circular.The leak was assessed with ice and determined that the pvl jet and the central tr jets were separate jets.It was decided to proceed with valve in valve (viv) because of the severe tr central leak.The orientation of the clips was biased at a diagonal angle, then these clips pushed into the frame, contributing to the frame compression.The patient left the room with a mild pvl and a stable valve.At full anchor flip, septal had restricted leaflet motion, looked pinned.Added about 1 cm of depth to unpin septal leaflet.Once the septal regained leaflet motion, took depth off.Proceeded with expansion as normal.The valve dropped 1-2cm below annulus upon release on anterior side.Did not observe oval compression of valve until full release.Level of outerframe shoulder appeared to be engaged with clips.It was attempted to snare the locking tab, but this did not work.The valve positioning did not change.Struggled with snare, but this did not raise the valve.The snare was released since it was not improving the valve position.The physician proceeded with viv, and there were no issues with the sapien deployment.The frame compression appeared to improved post-viv.The final result post sapien deployment was no central tr, still had mild pvl due to clips.Per internal imaging review, the 52 evoque device embolized into the ventricle intra-operatively, positioned >10 mm from the tv annulus.Severe tr and mild-moderate pvl were noted.A sapien viv was implanted with stable positioning, resolved tr, and mild residual pvl (tv mean gradient = 2 mmhg).Cannot confirm any device related issues or malfunction.Potential contributing factors: patient history (red case, prior teer x2), procedural (leaflet capture), and imaging (device shadowing).
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.Labelling review: the complaint for malposition - valve embolizes into ventricle was confirmed with objective evidence via imaging evaluation.Based on the device history record review, there were no non-conformances related to the issue observed and the device passed all manufacturing specifications.Available information suggests that contributing factors included the patient's history of prior teer procedures, incomplete leaflet capture during deployment, and imaging limitations due to device shadowing.Since no manufacturing non-conformances were found and no labeling, training, or ifu deficiencies were identified, no corrective or preventative actions were required.The complaint for central regurgitation was confirmed with objective evidence via imaging evaluation.Based on the device history record review, there were no non-conformances related to the issue observed and the device passed all manufacturing specifications.Available information suggests that the central regurgitation was due to the valve embolization.The contributing factors to the valve positioning difficulties include the patient's history of prior teer procedures, incomplete leaflet capture during deployment, and imaging limitations due to device shadowing.Since no manufacturing non-conformances were found and no labeling, training, or ifu deficiencies were identified, no corrective or preventative 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: 23011814
• Report Number: 2015691-2025-07428
• Device Sequence Number: 13259323
• Product Code: NPW
• UDI-Device Identifier: 00690103217469
• UDI-Public: (01)00690103217469(17)260807(11)240807
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/20/2025

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: 08/07/2026
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2024
• 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: Unknown