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

Model Number	9850EV44US
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/15/2026
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.On post operative day (pod) 50, the patient presented in clinic post-ttvr with bioprosthetic valve stenosis and acute heart failure.On follow-up evaluation, the reported mechanism of valve failure was thrombosis, per physician.It was confirmed that the patient had been anticoagulated.The patient was treated with iv heparin and was discharged after failing to show significant clinical improvement despite treatment with iv heparin.The physician decided to further treat the patient by implanting another valve within the existing evoque valve.Subsequently, the valve in valve was performed on pod 57 and the patient was discharged home.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6, and h11.Additional information: as per medical opinion, the perceived root cause of the event is that subtherapeutic inrs post-ttvr contributed to the event.The patient has a history of moderate aortic stenosis, complete heart block with permanent pacemaker, pulmonary hypertension, obstructive sleep apnea, and chronic anemia.The complaint for "thrombus formation (device) - post procedure" was confirmed with empirical evidence.The reported event does not allege or indicate that a device deficiency has occurred.Based on the device history record (dhr) review, there were no non-conformances related to the issue observed and the device passed all manufacturing specifications.Despite being on anticoagulation therapy, subtherapeutic inr levels were reported following the procedure, likely contributing to thrombus formation.Possible contributing factors to the thrombus formation can include patient factors (anticoagulant regiment, underlying coagulopathy), procedural factors, or a combination of these factors.Per tvarc, thrombosis/halt with or without restricted leaflet motion (rlm) are well-known complications of transcatheter aortic valve replacement that is also as likely to affect transcatheter tricuspid valve replacement due to lower pressures across the tricuspid.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 VALVE
• 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: 25111468
• Report Number: 2015691-2026-14978
• Device Sequence Number: 9292798
• Product Code: NPW
• UDI-Device Identifier: 00690103217445
• UDI-Public: (01)00690103217445(17)260514(11)240514
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P230013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 06/03/2026

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 Expiration Date: 05/14/2026
• 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: 04/15/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2024
• 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; Hospitalization
• Patient Sex: Female