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

Model Number	7300TFX
Medical Device Problem Codes	Calcified (1077); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Fatigue (1849); Insufficient Information (4580)
Date of Event	08/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: the device was not returned for evaluation, as the device request is ongoing.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
As per the report received from brazil, this valve model 7300tfx25mm was explanted after an implant duration of four (4) years and ten (10) months for unknown reason.A non-edwards mechanical valve was implanted in replacement.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b5, d4, d9, h3 and h6 (component code, clinical code, type of investigation, investigation findings and investigation conclusions).H11: additional manufacturer narrative: the device history record review was completed, and this device passed all manufacturing and sterilization inspections.There is one nonconformance attributed to this work order though they are not related to the complaint event.Per the product evaluation: customer reports of pannus and degeneration were confirmed through observed host tissue overgrowth.Report of regurgitation was unable to be confirmed through visual observations.X-ray demonstrated wireform intact and minimal calcification on all three leaflets.Moderate host tissue overgrowth encroached onto the tissue and into the orifice on leaflet 3 at the outflow aspect and on leaflet 3 at the inflow aspect.Host tissue fused leaflets 1 and 2, leaflets 1 and 3 and leaflets 2 and 3 by approximately 4mm on the outflow aspect.Host tissue on the stent circumference was moderate at both the inflow and outflow aspects.Calcification and host tissue overgrowth restricted leaflet mobility and led to stenosis.Pannus is a non-immune inflammatory reaction of the body to the implanted prosthesis, characterized by proliferation of fibroelastic tissue and collagen, with a starting point in the suture area and subacute or chronic centripetal evolution.Pannus can have both beneficial and harmful effects depending on the amount of growth and location.A small amount of host tissue growth over the suture line is expected and is needed to form a non-thrombogenic surface and complete the healing process after device implantation.In contrast, an excessive amount of pannus growth can cause nonstructural dysfunction that may require intervention.Host tissue growth can extend onto the cusp surfaces leading to thickening of the cusps, cusp retraction or curling, leaflet immobility, and/or abnormal coaptation, potentially resulting in valvular regurgitation, elevated gradients, and/or stenosis.Pannus/host tissue overgrowth is most likely due to patient factors and is unlikely to be related to a manufacturing non-conformance.In addition, structural valve degeneration (svd) is a logical and expected consequence of the chemical, mechanical, and immunological processes associated with bhv implantation.The common endpoint of all these factors is calcification and degradation.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.Prior investigations and extensive literature review have shown that svd is predominantly related to patient factors and implant duration rather than to manufacturing issues.Events related to device design, manufacturing, or use error tend to manifest at an earlier implant duration.Based on the information available, the root cause for the minimal calcification remains indeterminable as no patient or procedural factors known to cause or contribute to svd were reported.Since no edwards defect was identified, corrective or preventative actions are not required.
Event or Problem Description
Edwards received notification from brazil that this valve model 7300tfx25mm implanted in mitral position was explanted after an implant duration of four (4) years and ten (10) months due to degeneration and pannus leading to regurgitation.As reported, the patient presented with fatigue.A non-edwards mechanical valve was implanted in replacement.As reported, the patient was noted as to be in stable condition.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; one edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 22920765
• Report Number: 2015691-2025-07114
• Device Sequence Number: 16049782
• Product Code: DYE
• UDI-Device Identifier: 00690103186253
• UDI-Public: (01)00690103186253(17)231020(11)191021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: 10/20/2023
• Device Model Number: 7300TFX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2019
• 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; Required Intervention; Hospitalization
• Patient Sex: Female