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	Cardiac Perforation (2513)
Date of Event	12/12/2025
Type of Reportable Event	Death
Event or Problem Description
Edwards received notification of a transcatheter tricuspid valve replacement (ttvr) procedure involving the evoque system.Initial guidewire placement was at the right ventricular (rv) apex.The flex sections of the system were positioned in the mid-right atrium (ra), with the delivery system (ds) advanced across the tricuspid valve.One unit of depth was added from the capsule gap to the atrial flip.At the time of injury, the valve was fully expanded on the ventricular side, and the ds was being tilted anteriorly by advancing it forward.There was no intentional forward pressure applied to the guidewire to gain height, nor were there navigational maneuvers involving excessive guidewire force.Ventricular expansion of the valve proceeded without any issues or concerns.It was noted that the posterior anchor sat lower than the anterior anchor, prompting the interventional cardiologist (ic) to advance the ds by two clicks on the stabilizer.Immediately following this adjustment, the anesthesiologist reported a drop in blood pressure.An effusion sweep was performed, revealing a right atrial/right ventricular (ra/rv) pericardial effusion with complete cavity collapse consistent with tamponade.A pericardiocentesis was performed, protamine was administered, and cardiopulmonary resuscitation (cpr) was initiated.Cpr continued for approximately 30 minutes, during which 1 liter of blood was aspirated from the pericardial space.The ic ultimately made the decision to discontinue resuscitative efforts due to the absence of an underlying cardiac rhythm and the presence of clotting blood within the pericardial space, which prevented further reduction of the effusion.The patient subsequently expired, with the likely cause reported as rv perforation.Per internal imaging review, fluoroscopy demonstrated wire pressure, a more ventricular position of the nosecone, and incomplete visualization of the entire wire.No device-related malfunction was identified.The major root cause for the guidewire being pushed into the ventricular wall, as indicated by imaging, is procedure-related: suboptimal guidewire management.
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.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.No manufacturing non-conformities were identified from the imaging evaluation.Available information suggests that the guidewire likely caused unwanted interaction with the rv wall during delivery system manipulation.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 cook ; 1 edwards way; irvine, CA 92614 ; 5743778277
• MDR Report Key: 23866165
• Report Number: 2015691-2025-10431
• Device Sequence Number: 17478822
• Product Code: NPW
• UDI-Device Identifier: 00690103217520
• UDI-Public: (01)00690103217520(17)260409(11)250409
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 02/17/2026

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: 04/09/2026
• Device Model Number: 9850TDSUS
• Device Lot Number: 66493227
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• 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: Death
• Patient Sex: Female
• Patient Weight: 91 KG