MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS; REPLACEMENT HEART-VALVE

Model Number	2800TFX21MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a 21mm 2800tfx pericardial aortic valve underwent redo aortic valve replacement after an implant duration of eight (8) years, four (4) months due to patient prosthesis mismatch.The explanted valve was replaced with a 25mm 11500a inspiris valve.The patient was noted to be doing great post procedure.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections: b4, g3, g6, h2, h6 (type of investigation, investigation findings, and investigation conclusions).The device history record (dhr) review was completed, and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Engineering evaluation summary: per (b)(4), patient prosthesis mismatch (ppm) is present when the effective orifice area of the implanted bioprosthetic valve is too small in relation to body size.Literature indicates ppm main hemodynamic consequence is to generate higher than expected gradients through a normally functioning bioprosthetic valve.It has been shown to be associated with worse hemodynamic function, less regression of left ventricular hypertrophy, more cardiac events, and lower survival.Improperly sized valves with ppm can hasten the development of early degenerative changes and premature prosthetic valve dysfunction with varying degrees of prosthetic valve stenosis and regurgitation.Although ppm is a well-recognized phenomenon of bioprosthetic valves, it is most likely related to patient anatomical changes after long implant durations.When discovered intraoperatively or early post-operatively, ppm is most likely related to procedural factors, including specific patient assessment and valve model and size selection.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.Based on the available information, the root cause is indeterminable, however, the most likely root cause is patient and/or procedural factors.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 21776001
• Report Number: 2015691-2025-02611
• Device Sequence Number: 18597234
• Product Code: DYE
• UDI-Device Identifier: 00690103194081
• UDI-Public: (01)00690103194081(17)200601
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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
• Device Model Number: 2800TFX21MM
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/15/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male