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

Model Number	9850EV56US
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6b.If explanted, give date: device explanted date unknown.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.A few days post procedure, it was reported that the 56mm valve embolized into the ventricle.The evoque valve was explanted at an unknown date.The tricuspid valve was replaced surgically, and septal laceration from embolized evoque was repaired.The patient is improving and expected to get off ecmo.The patient's weight was down 2 kilograms, and annulus was measuring smaller than ct screening.Large coaptation gap which made identifying commissures very difficult.Intra procedural there was some difficulty capturing a portion of the posterior leaflet.Eventually it was believed that the posterior had been captured and proceeded as normal.At release there was trace/mild pvl posteriorly.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, and h11.After internal imaging review of pod2 tee, it was confirmed that there is evidence of the 56mm evoque valve embolized into the right ventricle with all anchors losing contact with the annulus.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: analysis of images.The complaint for malposition - valve embolizes into ventricle was confirmed with objective evidence via imaging evaluation.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.Internal review of post-operative day (pod) 2 tee confirmed the evoque valve embolized into ventricle with its septal aspect positioned near the right ventricular apex and the lateral aspect displaced toward the native tricuspid annular plane, with all anchors losing contact with the annulus.While the root cause cannot be identified from imaging, available information from the event description suggests that large commissures made leaflet capture difficult, specifically on the posterior leaflet.Additionally, at valve release there was trace/mild pvl posteriorly which could indicate lack of posterior leaflet capture.Therefore, the most likely cause of this event is due to a combination of patient factors (large commissures) and procedural factors (potential lack of leaflet capture).However, final leaflet capture is unable to be confirmed due to lack of procedure imaging.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 VALVE
• 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: 24552348
• Report Number: 2015691-2026-12692
• Device Sequence Number: 9386334
• Product Code: NPW
• UDI-Device Identifier: 00690103219074
• UDI-Public: (01)00690103219074(17)270203(11)250203
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P230013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/15/2026

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 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: 02/16/2026
• Supplement Date Received by Manufacturer: 03/13/2026; 04/14/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/06/2026; 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2025
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Weight: 98 KG