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

Model Number	6900P
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Device Stenosis (4066)
Health Effect - Clinical Codes	Dyspnea (1816); Insufficient Information (4580)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a 27mm 6900p mitral valve has been placed under evaluation/consideration for a valve-in-valve procedure after an implant duration of 7 years, 2 months due to stenosis and regurgitation.
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.
Additional Manufacturer Narrative
Updated sections: b2, b5, b7, g3, g6, h6 health effect - impact code, health effect - clinical code, 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 additional information that a patient with a 27mm 6900p mitral valve underwent a valve-in-valve procedure after an implant duration of 7 years, 3 months due to severe stenosis, severe transvalvular regurgitation with partial dehiscence.The patient presented with shortness of breath with exertion.The procedure was performed successfully with a 26mm9750tfx transcatheter valve.Per tee ((b)(6) 2025): severe ms, mmg 9, mva 0.8, mod/severe (3+) transvalvular mr, at most trace paravalvular.
Additional Manufacturer Narrative
Updated sections: g3, g6, h6 investigation findings, and 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.Device dehiscence or suture torn out may occur early or late.When it occurs in the intraoperative period, it is typically a result of inadequate device implantation in combination with friable myocardial tissue.Valve dehiscence is not a malfunction related to a manufacturing deficiency of the device.The instructions for use (ifu) have been reviewed, and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.A dhr review was performed, and no related manufacturing nonconformances were identified.The most likely root cause for the valve stenosis and dehiscence is patient factors, including implant duration of more than 7 years and patient history of atrial fibrillation, hypertension, heart failure, and coronary artery bypass graft.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PLUS 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: 22926671
• Report Number: 2015691-2025-07153
• Device Sequence Number: 13031567
• Product Code: DYE
• UDI-Device Identifier: 00690103152647
• UDI-Public: (01)00690103152647(17)200124
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2025

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: 01/24/2020
• Device Model Number: 6900P
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 09/12/2025; 10/07/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/07/2025; 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2016
• 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: Life Threatening; Required Intervention; Hospitalization; Other
• Patient Age: 84 YR
• Patient Sex: Female