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

Model Number	9850EV52US
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/16/2025
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.Prior to deployment, the anchors in the septal-lateral (sl) position were snug, while the anterior and posterior anchors had approximately 3-4 mm of space between the anchors and the annulus.During mpr spin, the anterior leaflet was difficult to assess.The secondary operator was unsure if leaflet was adequately captured, potentially caught on chord outside of anchor.During release, the anterior anchor came free from locking ring first.The delivery system (ds) migrated slightly posterior after anterior came off.The rest of anchors came off within seconds of the anterior.Upon deployment, the valve appeared stable and well-positioned.Approximately five seconds later, while maneuvering the ds out of the valve and away from the posterior locking tabs, the valve dropped on the anterior side.Mild anterior pvl was noted following this canting.After the valve shifted anteriorly, the interventional cardiologist snared the anterior locking tab, pulled upward, and deployed another valve.To further stabilize the valve, an additional valve was implanted as well.The valve remained stable with trace pvl on the anterior-septal side, which progressed to mild pvl by postoperative day (pod) 2.There was no patient injury associated with this event, and the patient remained in stable condition.
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 additional information received stating that it was noted on follow up imaging that patient was eventually converted to surgery due to evoque and viv complex rocking.The surgeon believed there was not full capture on the anterior side of the evoque valve.The complaint for valve deployed too ventricular was confirmed with empirical evidence via clinical specialist at the event and by a follow up imaging session.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.Procedural details and imaging indicate the valve instability was most likely due to suboptimal anterior anchor engagement driven by a posterior delivery trajectory.This positioning caused the anterior anchors to sit slightly low during anchor flip and atrial expansion, increasing the risk of interaction with sub-valvular structures and incomplete anterior leaflet capture.The combination of low anterior anchor positioning, probable chordal entanglement, and anchors deployed across multiple commissures led to anterior canting, pvl progression, double valve-in-valve procedures and an eventual valve rocking that necessitated surgical intervention.Since there are no confirmed product or labeling/ifu/training material non-conformances affecting distributed product and no other triggers have been met, no corrective or 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: 23990367
• Report Number: 2015691-2026-10229
• Device Sequence Number: 21392221
• Product Code: NPW
• UDI-Device Identifier: 00690103217469
• UDI-Public: (01)00690103217469(17)260915(11)240915
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 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: 09/15/2026
• Device Model Number: 9850EV52US
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2024
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 83 KG