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

Model Number	9850EV44US
Medical Device Problem Codes	Migration (4003); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Edwards received notification of a transcatheter tricuspid valve replacement (ttvr) procedure involving the evoque system where on post operative day (pod) 1 on the transthoracic echocardiogram (tte) it was observed the septal appeared lower as the final position of the valve and the central regurgitation was noted to have progressed to moderate to severe.Previously, the patient had moderate pvl posteriorly and mild central regurgitation post-deployment.There was no patient injury due to this event and no actions taken.The patient was noted to be in stable condition.Relatively uneventful procedure with some catheter shadowing.The leaflet capture confirmed on each anchor during the anchor spin.Posterior leaflet pinning observed post deployment.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.
Additional Manufacturer Narrative
B2: other serious- even though there was no reintervention, there is a potential for reintervention in this case.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: labelling review.The complaint for malposition - valve migrates from deployment position was confirmed with other empirical evidence by edwards personnel.Based on the device history record review, there were no non-conformances related to the issue observed and the device passed all manufacturing specifications.Potential contributing factors to these findings include suboptimal valve positioning and leaflet engagement, anchor placement and interaction with the annulus, as well as the patient's complex cardiac history, including a prior heart transplant.Since no manufacturing non-conformances were confirmed and no ifu/training deficiencies were identified, no corrective/preventative actions are required.The complaint for central regurgitation was confirmed with was confirmed with other empirical evidence by edwards personnel.Based on the device history record review, there were no non-conformances related to the issue observed and the device passed all manufacturing specifications.Potential contributing factors to central regurgitation include valve migration from deployment position which has potential contributing factors of operational context.Due to malposition, the valve follows path of least resistance into the ventricle and is not able to seal to the annulus.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: 22646461
• Report Number: 2015691-2025-06143
• Device Sequence Number: 8762456
• Product Code: NPW
• UDI-Device Identifier: 00690103217445
• UDI-Public: (01)00690103217445(17)270122(11)250122
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/03/2025

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: 9850EV44US
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2025
• 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: Other
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 62 KG