MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM; PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES

Model Number	9850EV56US
Medical Device Problem Codes	Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Code	Cardiogenic Shock (2262)
Type of Reportable Event	Death
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.B2: other serious- cardiogenic shock.
Event or Problem Description
Edwards received notification of an evoque valve in tricuspid position where, immediately upon deployment, implant was noted to be high on the lateral side of annulus.Moderate pvl (paravalvular leak) was noted in the lateral portion.Overall, the valve position was stable.Additional information received from the clinical specialist stated that the patient never left the hospital and had a cardiogenic shock.The patient then passed away.The cardiogenic shock was alleged to be related to the evoque valve.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, b5, g3, g6, h2, h6 and h11.
Event or Problem Description
After reviewing the post-operative day 2 tte (dated (b)(6) 2025), there is confirmation that the evoque valve embolized into the right atrium.The evoque valve is positioned more than 10mm from the tv annulus on the posterior, anterior, and lateral sides.The valve is unstable, exhibiting a rocking motion into the right atrium.There is trace transvalvular tr and moderate to severe lateral pvl.
Additional Manufacturer Narrative
Additional h6 type of investigation codes: analysis of images and labelling review.The complaint for malposition - valve embolizes into atrium was confirmed with objective evidence via the imaging evaluation from the pod 2 tte.Per the event description, the patient was reported to be stable following initial evoque deployment, with a moderate pvl.However, review of pod2 imaging revealed the evoque valve positioned low on posterior, anterior and lateral sides, causing most anchors to lose contact with the annulus.The valve was observed to have significant rocking motion into the right atrium.Patient was reported to have passed due to cardiogenic shock from the valve embolization approximately 1 month following the case.Malposition events such as embolization may be caused by a variety of factors such as device to native anatomy sizing (perimeter derived diameter), use factors and procedural factors.Patient was noted to have a minor weight reduction (9kg) following initial tee evaluation, changes in weight can potentially impact sizing.In conjecture, the patient was reported to have significant tethering on all leaflets.These factors may have contributed to the embolization of the evoque valve; however, a root cause was unable to be determined since procedural imaging was not provided for review to confirm reason for embolization.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.Since no edwards defect was identified, corrective or preventative actions are not 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: 21895733
• Report Number: 2015691-2025-03184
• Device Sequence Number: 3443058
• Product Code: NPW
• UDI-Device Identifier: 00690103219074
• UDI-Public: (01)00690103219074(17)260701(11)240701
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P230013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2025

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: 07/01/2026
• Device Model Number: 9850EV56US
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 04/29/2025; 06/05/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/22/2025; 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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; Other
• Patient Sex: Male