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

Model Number	7300TFX25
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849)
Date of Event	09/15/2025
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 25mm 7300tfx pericardial mitral valve was scheduled for valve-in-valve intervention after an implant duration of nine (9) years, nine (9) months due to moderate mitral regurgitation.The patient presented with dyspnea and fatigue.The patient was scheduled for intervention on (b)(6) 2025.The procedure was ultimately cancelled due to left atrial clot found while the patient was on the or table.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections: b4, g3, g6, h2, h6 (type of investigation, investigation findings, and investigation conclusions).Engineering evaluation summary: per (b)(4), 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 insufficient information available regarding patient or procedural factors known to cause or contribute to regurgitation.Therefore, a definitive root cause cannot be conclusively determined.H11: corrective data: investigative result was inadvertently omitted when submitting medwatch # (b)(4).All pertinent information has been included in this medwatch report.
Event or Problem Description
It was reported that a patient with a 25mm 7300tfx pericardial mitral valve underwent valve-in-valve intervention after an implant duration of nine (9) years, 11 months due to moderate mitral regurgitation.The patient presented with dyspnea and fatigue.The patient was originally scheduled for intervention on (b)(6) 2025 but was then cancelled due to left atrial clot found while the patient was on the or table.The tmvr procedure was successfully performed after an implant duration of 10 years, one (1) month resulting in the implant of a 26mm 9750tfx transcatheter valve.
Additional Manufacturer Narrative
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 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: 23831274
• Report Number: 2015691-2025-10285
• Device Sequence Number: 9278046
• Product Code: DYE
• UDI-Device Identifier: 00690103186253
• UDI-Public: (01)00690103186253(17)190513
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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,Followup
• Report Date (Section B): 02/09/2026

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
• Device Expiration Date: 05/13/2019
• Device Model Number: 7300TFX25
• Device Catalogue Number: 4495214
• 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: 09/15/2025
• Supplement Date Received by Manufacturer: 12/24/2025; 01/27/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 12/31/2025; 02/09/2026
• Date Device Manufactured: 05/14/2015
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 70 YR
• Patient Sex: Female