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	12/31/2025
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.The wire was briefly utilized for a height gain attempt and then retracted.It was noted to be clear on wire check and no wire deformation or kinking.No significant wire pressure was noted prior to wire push or after.Deployment proceeded without incident until full ventricular expansion, at which point hypotension was observed.Echocardiography identified a pericardial effusion.The valve was deployed under echocardiographic guidance.Chest compressions performed during atrial expansion.Valve released quickly as it appeared to have some built up tension and during release the delivery system (ds) may have potentially shifted very minorly and added some pressure onto the wire.The shift was not enough to be noticed by echo and difficult to confirm.The valve was implanted successfully and working appropriately with no leak observed.Pericardiocentesis was performed, and more than 2 liters of blood were removed with no resolution to the effusion.The procedure was converted to a mini sternotomy and pericardial window.The surgeon repaired a small laceration of the right ventricular (rv) wall by stitching the rv which he said the tissue was very friable.The patient was reported to be alive and in stable condition.The interventional cardiologist felt that the patient's history of having prior chest radiation and chemotherapy contributed to the fragility of the rv.
Additional Manufacturer Narrative
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.Available information suggests that the guidewire likely caused unwanted interaction with the rv wall during delivery system manipulation.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: 24109178
• Report Number: 2015691-2026-10480
• Device Sequence Number: 5879253
• Product Code: NPW
• UDI-Device Identifier: 00690103217520
• UDI-Public: (01)00690103217520(17)260602(11)250602
• 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): 02/24/2026

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: 06/02/2026
• Device Model Number: 9850TDSUS
• Device Lot Number: 66691551
• 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: 12/31/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2025
• 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