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

Model Number	7300TFX
Medical Device Problem Codes	Degraded (1153); Thickening of Material (4056)
Health Effect - Clinical Codes	Dyspnea (1816); Insufficient Information (4580)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available for evaluation, as it remains implanted in the patient.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 27mm 7300tfx mitral valve underwent a valve-in-valve procedure after an approximately implant duration of 7 years, 7 months due to thickened leaflets with stenosis with a mitral gradient (mg) of 16 mm hg.The patient underwent tmvr with a 26mm 9755rsl transcatheter valve.The patient was stable at the end of the procedure.
Additional Manufacturer Narrative
Updated sections: b5, b7, d6a, g3, g6, h6 device code(s), and type of investigation.The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.
Event or Problem Description
It was reported and through investigation that a patient with a 27mm 7300tfx mitral valve underwent a valve-in-valve procedure after an implant duration of 8 years, 3 months due to degeneration with, thickened leaflets with 3-4+ regurgitation, stenosis.The patient presented with shortness of breath.The patient underwent tmvr with a 26mm 9755rsl transcatheter valve.The patient was stable at the end of the procedure.
Additional Manufacturer Narrative
Updated sections: g3, g6, h6 investigation findings, and investigation conclusions.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.Despite the advancements in the heart valve industry, svd commonly begins 7- 8 years after implantation, with a considerably increased rate in patients with pertinent comorbidities and/or an implant duration of greater than 10 years.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.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.Based on the information available, the most likely root cause is patient factors, including an implant duration of 7 or more years, hyperlipidemia (hld) and diabetes mellitus (dm).
Event or Problem Description
It was reported and through investigation that a patient with a 27mm 7300tfx mitral valve underwent a valve-in-valve procedure after an approximately implant duration of 7 years, 7 months due to thickened leaflets with stenosis with a mitral gradient (mg) of 16 mm hg.The patient presented with shortness of breath.The patient underwent tmvr with a 26mm 9755rsl transcatheter valve.The patient was stable at the end of the procedure.
Additional Manufacturer Narrative
Updated sections: b5, b7, g3, g6, h6 health effect - clinical code.

• 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: 23031089
• Report Number: 2015691-2025-07495
• Device Sequence Number: 13187041
• Product Code: DYE
• UDI-Device Identifier: 00690103186260
• UDI-Public: (01)00690103186260(17)210109
• 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: 2017
• 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): 10/28/2025

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: 01/09/2021
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 09/19/2025; 10/14/2025; 10/27/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/15/2025; 10/20/2025; 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2017
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Female