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

Model Number	9850EV48US
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
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 an evoque procedure in tricuspid position where upon final release, valve appeared unstable then migrated ventricular.To stabilize, 2 snares were placed (one from groin, one from ij) to hold the evoque in place, while sapien 29 mm was prepped.Sapien was deployed and evoque valve was stabilized.There was mild-mod leak after that was confirmed with tee but the physician did not feel like post dilating would be beneficial at this time so the physician wants to let it endothelialize and then re-evaluate.There was mild pvl between evoque and sapien.Patient was stable immediately post procedure.Additional information received reporting that the previous annuloplasty band had minor dehiscence which may have impacted shadowing.
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: analysis of images.Labelling review.Based on the complaint investigation, the complaint for malposition - valve embolizes into ventricle 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.The imaging evaluation demonstrated that this case was categorized as a red case for high complexity due to the patient having a prior tricuspid annuloplasty ring with a small dehiscence in the posterior-lateral aspect of the annulus.The pre-existing device and dehiscence also added to the complexity of the procedure due to increased shadowing on echo imaging.It was observed that two anchors of the device appear pinned on the anterior side of the valve during atrial flip, and ventricular expansion.However, visibility is lost after ventricular expansion and it is unclear whether these anchors were un-pinned later in the procedure.Upon deployment, the posterior and lateral aspects of the evoque valve dropped ventricularly, with the majority of anchors over 10mm from the annulus.The available information suggests that the root cause of the event is due to patient conditions (prior tricuspid annuloplasty ring).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.No preventative or corrective actions are required because there are no confirmed product or labeling/ifu/training material non-conformances affecting distributed product and no other triggers have been met.

• 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: 22340726
• Report Number: 2015691-2025-05155
• Device Sequence Number: 18434793
• Product Code: NPW
• UDI-Device Identifier: 00690103217452
• UDI-Public: (01)00690103217452(17)261202(11)241202
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/20/2025

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: 9850EV48US
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2024
• 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: Required Intervention
• Patient Sex: Female