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	04/20/2026
Type of Reportable Event	Death
Event or Problem Description
Edwards received notification of a transcatheter tricuspid valve replacement (ttvr) procedure involving the evoque system where a right ventricular (rv) perforation occurred.Pericardiocentesis was performed first, but accessing the pericardium proved challenging and took longer than usual.The patient was subsequently converted to surgery and underwent open heart surgery for repair of the laceration with suture and was in stable condition.However, one or two days post procedure the patient expired.Perforation likely occurred during valve crossing and did not progress beyond that point.The team decided to reposition the probe and equipment to the opposite side, moving underneath the catheter.During this process, something (possibly the lead shield) unintentionally bumped the delivery system, likely pushing the wire into the ventricle.Subsequently, a drop in pressure was observed either during crossing or shortly thereafter, and effusion was identified once the machines were restarted.Initial guidewire placement was within the posterior pocket.The wire curl was along the posterior wall in relation to the anatomy.At the time the perforation occurred, the system had been advanced into position and imaging was planned to confirm positioning and trajectories.No intentional advancement of the guidewire to obtain height or navigational maneuvers involving excessive force were reported.
Additional Manufacturer Narrative
B2 date of death: exact date unknown.Approximately one or two days post procedure the patient expired.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 reported 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 the guidewire interaction with the right ventricular (rv) wall during delivery system crossing contributed to the reported event.No device malfunction was identified.The delivery system and guidewire functioned as intended, with no evidence of structural defect or failure.The injury was attributed to procedural handling, specifically the unintended guidewire advancement resulting from external contact with the delivery system, leading to rv wall perforation.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: 25144308
• Report Number: 2015691-2026-15089
• Device Sequence Number: 9543470
• Product Code: NPW
• UDI-Device Identifier: 00690103217520
• UDI-Public: (01)00690103217520(17)260612(11)250612
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/17/2026

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: 06/12/2026
• Device Model Number: 9850TDSUS
• Device Lot Number: 66741774
• 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: 04/20/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2025
• 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 Age: 82 YR
• Patient Sex: Female
• Patient Weight: 75 KG