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

Model Number	9850TDSUS
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Intraoperative Cardiac Valve Injury (4852)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Edwards received notification of a transcatheter tricuspid valve replacement (ttvr) procedure involving the evoque system.The delivery system was over the safari wire when a torn papillary muscle/ flail leaflet was noted.The procedure was aborted.The patient was reported to be in stable condition, with no patient injury noted and no additional actions taken.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6 and h11.Additional information received stating that the procedure was completed the following day.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.Labelling review.The complaint for delivery system and/or guidewire pushed into ventricular wall was confirmed with objective evidence.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 that advancement of the delivery system over the wire may have caused unwanted interaction, contributing to the reported event.During the second evoque procedure performed one day post initial evoque procedure, the flail posterior leaflet was present at baseline prior to device manipulation.The evoque valve was subsequently deployed successfully and appeared stable based on the limited imaging available.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: 23879805
• Report Number: 2015691-2025-10513
• Device Sequence Number: 9605170
• Product Code: NPW
• UDI-Device Identifier: 00690103217520
• UDI-Public: (01)00690103217520(17)260508(11)250508
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P230013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2026

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: 05/08/2026
• Device Model Number: 9850TDSUS
• Device Lot Number: 66642397
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/19/2026; 02/09/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/02/2026; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2025
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 71 KG