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 Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	07/16/2025
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 33mm 7300tfx mitral valve has been placed under evaluation for a valve-in-valve procedure after an implant duration of 9 years and 10 months due to stenosis.The patient presented with symptoms of heart failure.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections g3, g6, h2, h6 (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 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 type of event 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 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 33mm 7300tfx mitral valve was under evaluation for a valve-in-valve procedure after an implant duration of 9 years and 10 months due to stenosis.The patient presented with symptoms of heart failure.It was learned patient successfully underwent tmvr with a 29mm 9600tfx transcatheter valve.The patient was recovering in stable condition post-procedure.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections b2, b5, g3, g6, h2, h6 (impact code).H11: corrected data: h6, (type of investigation, investigation conclusions).Svd is an acquired condition, intrinsic to bioprosthetic valves, characterized by deterioration of the leaflets or supporting structures, leading to thickening, calcification, tearing, or disruption of the prosthetic valve materials.These changes result in valvular dysfunction manifesting as stenosis and/or regurgitation with a consequent drop in hemodynamic efficacy of the valve.Svd commonly occurs with a considerably increased rate after 10 years.Prior investigations and extensive literature review have shown that it is predominantly related to patient factors and implant duration rather than to manufacturing issues.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.Based on the information available, the most likely cause is patient factors, including an implant duration of 10 or more years.The subject device is not available for evaluation as it remains implanted in the patient.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 type of event is included in the ifu.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 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 33mm 7300tfx mitral valve was under evaluation for a valve-in-valve procedure after an implant duration of 10 years and 1 month due to stenosis.The patient presented with symptoms of heart failure.It was learned patient successfully underwent tmvr with a 29mm 9600tfx transcatheter valve.The patient was recovering in stable condition post-procedure.
Additional Manufacturer Narrative
H11: corrected data: b5 (describe event or problem).

• 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: 22751095
• Report Number: 2015691-2025-06477
• Device Sequence Number: 18321954
• Product Code: DYE
• UDI-Device Identifier: 00690103186291
• UDI-Public: (01)00690103186291(17)190107
• 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: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/30/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2019
• Device Model Number: 7300TFX
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 08/29/2025; 09/30/2025; 10/30/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/10/2025; 10/20/2025; 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2015
• 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: Life Threatening; Other; Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male