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	10/03/2025
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 where the guidewire was sitting at the apex of the right ventricle (rv) when the perforation occurred.The perforation/pericardial effusion was caused by the wire.The initial guidewire placement was easy, uneventful and on posterior septal.Free wire at wire check and wire position was appropriate.No significant wire pressure observed during crossing, crossing was slow and controlled due to proximity of pacing lead.The delivery system (ds) crossing was slow and controlled and managed wire while crossing.The wire advanced more apically after crossing the valve with more of the stiff section exposed from the ds and there was possible tension at the ivc level.The wire was retracted, and anesthesia noted a drop in the patient's blood pressure.Echo was done and there was a large pericardial effusion observed.The ds was across the valve when the perforation occurred.There was no other indication on fluoro other than wire curl appearing deeper and deformation of the curl.There was no intentional push on the guidewire to obtain height and/or navigational maneuvers with excess force already on the guidewire.Ic did not feel like he had unusual wire pressure.As per medical opinion, the perceived root cause of the event was a combination of friable rv (per cardiothoracic surgeon) and not enough wire tension.Cardiopulmonary resuscitation (cpr) was performed and procedure was converted to open heart to repair the perforation and stabilize the patient.The patient's final outcome was reported to be awake, responsive and 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: 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.The available information indicates that wire management combined with challenging patient anatomy were the likely root causes of the rv injury.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: 23359617
• Report Number: 2015691-2025-08721
• Device Sequence Number: 8965058
• Product Code: NPW
• UDI-Device Identifier: 00690103217520
• UDI-Public: (01)00690103217520(17)260318(11)250318
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/15/2025

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: 03/18/2026
• Device Model Number: 9850TDSUS
• Device Lot Number: 66360557
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2025
• 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 Age: 82 YR
• Patient Sex: Female
• Patient Weight: 73 KG