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

Model Number	9850EV56US
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/19/2025
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.During the procedure, a pigtail was used to place the wire.At one point, the maneuvers on the delivery system were not translating properly and we were stuck posteriorly, but we were able to get centered and coaxial prior to deployment.Once the valve was deployed, the valve canted slightly anterior septal, but the valve was stable with trace paravalvular leak (pvl)/diastolic competitive flow found on the septal side.The patient had a follow-up transthoracic echo (tte) a few hours after the procedure, and the valve canted even more on the anterior side, causing a severe pvl shown by color doppler on tte and tee.A 29 mm sapien valve was successfully implanted within the 56 mm evoque valve to restabilize the valve, and most of the pvl was sealed.There was appropriate volume optimization the day of the procedure.There was nothing to note with respect to patient anatomy that impacted the sealing.There was no patient injury due to this event and the patient was reported to be in stable condition.The reported potential root cause of the event was that the system became stuck in the posterior position and was maneuvered into the anterior space, which may have resulted in unintended contact with anatomy.Device movements did not translate as expected due to this obstruction; advancing or retracting caused pivoting and increased trajectory rather than positional movement.Tilting maneuvers were used to align the anterior portion of the valve at the hinge point during anatomical contact.The valve appeared appropriately positioned prior to deployment.During removal of primary flexes and delivery system extraction, initial attempts were ineffective.Kinking of the outer capsule was observed, and slight retraction caused the delivery system to move anteriorly abruptly.The valve was not impacted during this process.
Additional Manufacturer Narrative
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.The complaint for malposition - valve migrates from deployment position was confirmed with empirical 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 interaction with sub valvular structures likely contributed to the reported event.Imaging review showed the anterior aspect of the valve appearing more ventricular.However, no procedural tee was provided to assess procedural workflow and valve positioning prior to release.Since no manufacturing non-conformances were found and no labeling, training, or ifu deficiencies were identified, no preventative or corrective 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 ; 1 edwards way; irvine, CA 92614 ; 5743778277
• MDR Report Key: 23769834
• Report Number: 2015691-2025-09918
• Device Sequence Number: 21268001
• Product Code: NPW
• UDI-Device Identifier: 00690103219074
• UDI-Public: (01)00690103219074(17)261118(11)241118
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/16/2026

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 Model Number: 9850EV56US
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 46 KG