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

Model Number	9850EV56US
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.B2: other serious- even though there was no reintervention, there is a potential for reintervention in this case.
Event or Problem Description
Edwards received a report of an evoque procedure in tricuspid position where an echo was done while the patient was still in the hospital at some unspecified point post procedure, and halt was seen on the evoque valve, and the patient was put on iv heparin.The mean gradient through the valve was 5mmhg.The patient was discharged on warfarin and last reported inr was 1.3 prior to discharge.
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: labeling review.The complaint for leaflet thickened thrombus formation (device) post procedure was confirmed with empirical evidence from the complaint description.The device history record review was completed, and this device passed all manufacturing and sterilization inspections.No non-conformances related to the complaint event were identified.The reported adverse event does not allege or indicate any edwards device deficiencies.Potential contributing factors for this event can include patient health, procedural factors, or a combination of these factors.No imaging or device returned for investigation.Based on extensive complaint investigations, these events of leaflet thickened complaints and/or thrombus formation (device) post procedure are likely related to patient factors (e.G.Anticoagulant regiment, underlying coagulopathy), procedural factors, or a combination of these factors and are not attributed to device malfunctions or manufacturing nonconformances.The evoque ifu provides adequate instruction on device usage and valve placement.These events will continue to be monitored and complaints trending and control limits are managed and assessed.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: 21940013
• Report Number: 2015691-2025-03415
• Device Sequence Number: 8553692
• Product Code: NPW
• UDI-Device Identifier: 00690103219074
• UDI-Public: (01)00690103219074(17)261118(11)241118
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 06/10/2025

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 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: 04/10/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• 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: Other
• Patient Sex: Unknown