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

Model Number	9850EV44US
Medical Device Problem Codes	Migration (4003); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Edwards received notification of an evoque valve in tricuspid position where it was reported that the valve malpositioned post deployment.During the procedure, the placement was somewhat deep after initial crossing but wire push achieved adequate height for capsule gap and subsequent capsule reveal.Some mild compromises on position and trajectory but quite straightforward for an internal jugular approach.Carcinoid leaflets allowed for leaflet capture very early in anchor reveal and the team was able to bring the valve near the annular plane for full valve deployment.After release of the valve, it settled more ventricular most prominently in anterior/septal aspect.Valve noted to be stable but with mild-moderate pvl anterior/septal, and moderate-severe central regurgitation.Additionally, there looked to be some sluggishness of the evoque leaflets resulting in regurgitation.No intervention planned at this time.
Additional Manufacturer Narrative
The event is captured by edwards lifesciences under complaint #: (b)(4).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.The complaint for malposition - valve embolizes into ventricle was confirmed with objective evidence.No manufacturing or functional non-conformities were found or identified from the imaging evaluation.The imaging evaluation indicated that during the valve deployment procedure, the valve was deployed too ventricular on the septal, anterior, lateral region.Potential contributing factors to the valve deployed too ventricular are plastered leaflets and suboptimal mpr imaging during leaflet capture based on the review of the images provided.No manufacturing or functional non-conformities were identified from the imaging evaluation.Since no manufacturing non-conformances were found and no labeling, training, or ifu deficiencies were identified, no preventative or corrective actions were required.The complaint for central regurgitation was confirmed with objective evidence.No manufacturing non-conformities were identified from the imaging evaluation.Imaging observed residual qualitatively moderate to severe transvalvular central tr.Due to the limited patient medical information, a definite root cause is unable to be determined.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: 20615823
• Report Number: 2015691-2024-08341
• Device Sequence Number: 12600997
• Product Code: NPW
• UDI-Device Identifier: 00690103217445
• UDI-Public: (01)00690103217445(17)260604(11)240604
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P230013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/16/2024

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: 06/04/2026
• Device Model Number: 9850EV44US
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2024
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Weight: 62 KG