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

Model Number	7300TFX
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Dyspnea (1816); Insufficient Information (4580)
Date of Event	08/01/2025
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 mitral valve has been placed under evaluation for a valve-in-valve procedure after an implant duration of 7 years and 5 months due to severe mitral stenosis and moderate mitral regurgitation.
Event or Problem Description
It was reported that a patient with a 31mm 7300tfx mitral valve underwent a valve-in-valve procedure after an implant duration of 7 years, 5 months due to severe mitral stenosis and moderate mitral regurgitation.The procedure was performed with a 29mm 9600tfx transcatheter valve.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated section b3 and b5.G3 (date received by manufacturer) and g6 (type of report and follow-up number filled out.) updated section h2 (follow-up type) and h6 codes - (impact codes).
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections b5, g3, g6, h2, h6 (clinical code, type of investigation, investigation findings, investigation conclusions).Stenosis is a common manifestation of bioprosthetic valve and valved conduit dysfunction and has many potential root causes, including structural valve deterioration (svd), non-structural valve dysfunction (nsvd), endocarditis and/or thrombosis.Bioprosthetic device stenosis is typically related to patient and/or procedural factors and is not typically an indication of a device malfunction related to a manufacturing deficiency." there is no evidence to suggest a manufacturing defect caused or contributed to the reported event.There is no evidence to suggest a manufacturing defect caused or contributed to the svd.There is insufficient information available regarding patient or procedural factors known to cause or contribute to stenosis.Therefore, a definitive root cause cannot be conclusively determined.The instructions for use (ifu) have been reviewed, and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported svd is included in the ifu.The subject device is not available for evaluation as it remains implanted in the patient.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.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If new information becomes available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a patient with a 31mm 7300tfx mitral valve underwent a valve-in-valve procedure after an implant duration of 7 years, 5 months due to severe mitral stenosis and moderate mitral regurgitation.The patient presented with shortness of breath.The procedure was performed with a 29mm 9600tfx transcatheter valve.The patient was taken to post-anesthesia care unit after the procedure.

• 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 LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 22714028
• Report Number: 2015691-2025-06338
• Device Sequence Number: 13053852
• Product Code: DYE
• UDI-Device Identifier: 00690103186284
• UDI-Public: (01)00690103186284(17)200710
• 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: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2020
• Device Model Number: 7300TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 08/12/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 08/28/2025; 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2016
• 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; Life Threatening; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male