MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EVOQUE DELIVERY 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	02/17/2026
Type of Reportable Event	Death
Event or Problem Description
Edwards received notification of a transcatheter tricuspid valve replacement (ttvr) procedure involving the evoque system.An effusion was noted as soon as the delivery system (ds) crossed the valve.There was a 1cm laceration noted at the rv apex.The patient was converted to an unplanned thoracic or cardiac surgery.The patient was stable after the right ventricle was repaired.However, the patient developed disseminated intravascular coagulation (dic) overnight, the family chose to withdraw support and the patient expired.Dic was confirmed to be the cause of death.During index procedure, the cath lab staff were managing the wire with ic direction.No pigtail was used.The wire curl with located post apex, in the pocket between paps.The wire was clear of anatomy during wire check.Wire push was not used for height.No evidence of wire mismanagement, wire curled around anatomy, excessive pressure on wire curl, or wire deformation or kinking.
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 perforation of atrial/ventricular wall was confirmed with 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.Available information suggests that procedural manipulation in a trabeculated right ventricle contributed to the reported event.No device malfunction, delivery system deformation, or manufacturing defect was identified based on the information currently available.There was no documented change in delivery system position relative to the guidewire, and no procedural deviation, excessive force, or inappropriate manipulation was identified as a definitive initiating cause.While interaction between the delivery system and the rv apex in the presence of apical trabeculation and a pre existing effusion is considered a possible contributing mechanism, there is no direct procedural or imaging evidence confirming a specific causative interaction at the time of 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 DELIVERY 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: 24558620
• Report Number: 2015691-2026-13080
• Device Sequence Number: 18358000
• Product Code: NPW
• UDI-Device Identifier: 00690103217520
• UDI-Public: (01)00690103217520(17)260423(11)250423
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/15/2026

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: 04/23/2026
• Device Model Number: 9850TDSUS
• Device Lot Number: 66551889
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2025
• 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