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	08/26/2025
Type of Reportable Event	Death
Event or Problem Description
Edwards received notification of a transcatheter tricuspid valve replacement (ttvr) procedure using the evoque system where initial guidewire placement was challenging due to trajectory issues near the rvot.The team recrossed and used a pigtail for the second attempt; the wire curl retracted to mid-ventricle, indicating it was free of anatomy.At time-out, the physician had an anterior trajectory that could not be corrected due to significant secondary flex, and the team agreed to proceed.Anchor deployment showed an excellent septal-lateral (s/l) window, but the posterior-anterior (a/p) view worsened as the outer capsule retracted.At 90 degrees, all leaflets were confirmed over the anchors.S/l was coaxial and central, while a/p had a posterior position with anterior trajectory.Attempts to correct with system advancement and wire push had limited effect.After a half-atrial flip, leaflets remained inside anchors, but s/l shifted laterally.Secondary flex was reduced to regain a/p control, but posterior anchors did not move atrially, and lateral anchors dropped.Additional wire pressure improved anchor height, though no excessive pressure was seen on fluoroscopy.The wire curl appeared significantly deeper than the icd lead.Anesthesia reported severe hypotension.Imaging switched from ice to tee, revealing a pericardial effusion.Pericardiocentesis was initiated, but bleeding persisted.The cardiac surgeon performed a sternotomy and opened the pericardium, improving cardiac function.The wire curl was visualized exiting the rv apex, confirming a major rv laceration.Despite transfusions and cell saver, blood loss was massive, and resuscitation failed.The perceived root cause was wire pressure likely causing rv perforation with the stiff portion of the wire.The curl then exited the rv apex, creating a large laceration, leading to hemodynamic collapse and fatal blood loss.The wire was free in the apex at the time, and the delivery system was in-line with no prior warning signs.
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 other empirical evidence.Based on the device history record review, there were no non-conformances related to the issue observed and the device passed all manufacturing specifications.Available information suggests that challenging wire manipulation due to anatomical complexity was the likely root cause of the rv injury event.Imaging review was limited, with only two fluoroscopic images provided.The images show the pigtail in the right atrium and the wire in the right ventricle, with no evidence of guidewire pressure and no images of the delivery system.This limitation hindered the ability to fully assess the mechanical interaction between the wire and the ventricular wall at the time of injury.No device malfunction was identified.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: 23044289
• Report Number: 2015691-2025-07550
• Device Sequence Number: 13275359
• Product Code: NPW
• UDI-Device Identifier: 00690103217520
• UDI-Public: (01)00690103217520(17)260407(11)250407
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/27/2025

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: 04/07/2026
• Device Model Number: 9850TDSUS
• Device Lot Number: 66493226
• 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: 08/26/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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: Required Intervention; Death
• Patient Sex: Female