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

Model Number	9850EV48US
Medical Device Problem Codes	Malposition of Device (2616); Migration (4003); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Foreign Body Embolism (4439)
Date of Event	10/26/2025
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.Upon final valve release, the device dropped more than 1 cm anteriorly/laterally.The valve remained stable, but moderate paravalvular leak (pvl) and severe central tricuspid regurgitation (tr) were observed; imaging localized pvl to the anterior position.Patient blood pressure was low (60-70 mmhg) under full support.A valve-in-valve procedure was performed: the evoque valve was secured with a snare, and a 29 mm s3ur valve was implanted with +2 cc inflation.Post-intervention, pvl reduced to mild, tr resolved, valve stability confirmed, and blood pressure improved to 90-110 mmhg.No patient injury occurred; patient remained stable.History included carcinoid disease managed with octreotide; imaging was challenging, requiring ice.Valve expansion appeared appropriate prior to release; posterior capture was briefly lost during ventricular expansion but recaptured.Root cause likely related to carcinoid disease.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6 and h11.Additional information received stating that per internal imaging review, there is evidence of device embolization.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 maposition - valve embolizes into ventricle was confirmed with objective evidence via imaging evaluation.Available information suggests that patient-related factors (carcinoid disease) and procedural issues (suboptimal depth, lack of leaflet capture) could have contributed to the reported event.This patient had significant septal leaflet plastering (>1/2 of leaflet), significant leaflet tethering (>10mm and large coaptation gap), and leaflet continuity.The complaint for central regurgitation was confirmed with objective evidence via imaging evaluation.Per the imaging evaluation, there is confirmation of a significant, moderate (pvl), and central tricuspid regurgitation with device instability.Improper valve sealing can result from the embolization of the evoque valve and thus result in central regurgitation.As such, available information suggests procedural factors (valve embolization due patient factors and procedural issues) had likely contributed to central regurgitation.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.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: 23573144
• Report Number: 2015691-2025-09318
• Device Sequence Number: 9868696
• Product Code: NPW
• UDI-Device Identifier: 00690103217452
• UDI-Public: (01)00690103217452(17)260722(11)240722
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 12/18/2025

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: 07/22/2026
• Device Model Number: 9850EV48US
• 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: 10/26/2025
• Supplement Date Received by Manufacturer: 11/19/2025; 12/17/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/08/2025; 12/18/2025
• Date Device Manufactured: 07/22/2024
• 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 Age: 67 YR
• Patient Sex: Male