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

Model Number	7300TFX31
Medical Device Problem Codes	Fluid/Blood Leak (1250); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that a patient with a 31mm 7300tfx pericardial mitral valve underwent valve-in-valve intervention after an implant duration of eight (8) years, 11 months due to central aortic insufficiency.The tmvr procedure was performed with a 29mm 9755rsl transcatheter valve.The patient left the procedure in stable condition.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated: b4, d4, g3, g6, h2, h4, h6.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Regurgitation identified post-procedurally has many potential root causes, including structural valve deterioration (svd), non-structural valve dysfunction (nsvd), endocarditis and/or thrombosis.Regurgitation occurring post-procedurally is most commonly related to patient and/or procedural factors and is not typically an indication of a device malfunction related to a manufacturing non-conformance.A device history record (dhr) review was performed, and no relevant non-conformances were identified.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.There is insufficient information available regarding patient or procedural factors known to cause or contribute to regurgitation.Therefore, a definitive root cause cannot be conclusively determined.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE 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: 22861884
• Report Number: 2015691-2025-06880
• Device Sequence Number: 9404134
• Product Code: DYE
• UDI-Device Identifier: 00690103186284
• UDI-Public: (01)00690103186284(17)200707
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 09/30/2025

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 Expiration Date: 07/07/2020
• Device Model Number: 7300TFX31
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/30/2025
• Date Device Manufactured: 07/08/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male