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	10/07/2025
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 where the physician opted for left jugular approach due to the patient having a heavily trabeculated right ventricle (rv), small ra, and prominent eridge.The wire path was established per recommendation (no pigtail) curl of wire established in ra and pushed into rv freely.While positioning the wire posteriorly (as is typical for jugular access), it initially rested atop the rv trabeculations causing the wire curl to partially enter the tv annulus, too close to the atrium.The wire was advanced and sat further into rv towards the rv free wall/anterior (right where the trabeculations became less prominent).The delivery system (ds) was inserted and advanced/crossed into rv per typical procedure, but pressures dropped immediately after crossing and a significant effusion was noted.Unable to identify area of laceration on echo due to significant rv collapse (cardiac tamponade).The delivery system was left in while efforts to drain effusion started via pericardiocentesis and compressions were started at the same time as it was noted on echo there was little to no rv/lv contraction or output.Once patient was tapped after about 5-10 minutes, function was regaining as well as pressures.The surgeon was called and patient was opened on table.The delivery system was removed.It was looked at multiple times on echo for any indication that wire or ds were in pericardial space but no evidence of this was noted.Identified the root cause as forward wire pressure during crossing.The surgeon stated that a laceration of the anterior rv free wall was found and repaired.The patient stabilized and there was no intervention made on the tricuspid valve.
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: labelling review.The complaint for delivery system and/or guidewire pushed into ventricular wall was confirmed with other 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.The available information indicates that challenging wire manipulation combined with complex patient anatomy were the likely root causes of the rv injury.The patient had a heavily trabeculated right ventricle (rv), small right atrium (ra), and a prominent eustachian ridge, which made wire positioning difficult.During delivery system (ds) insertion and crossing into the rv, forward wire pressure was applied to gain height and facilitate advancement, which likely transmitted force to the thin anterior rv wall.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: 23384434
• Report Number: 2015691-2025-08804
• Device Sequence Number: 18340601
• Product Code: NPW
• UDI-Device Identifier: 00690103217520
• UDI-Public: (01)00690103217520(17)260409(11)250409
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/04/2025

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: 04/09/2026
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/04/2025
• 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: Required Intervention
• Patient Sex: Female