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

Model Number	6900PTFX
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The most likely root cause is patient factors, including hyperlipidemia.The root cause of this event cannot be conclusively determined with the available information.However, the stenosis in this case was most likely impacted by the progression of the patients underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.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 25mm 6900ptfx mitral valve, underwent a valve-in-valve procedure after an implant duration of 5 years and 6 months due to stenosis.The patient was presented with heart failure and shortness of breath.The valve was replaced with a 2mm 9755rsl transcatheter valve.The patient was stable post procedure.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PLUS MITRAL PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492500222
• MDR Report Key: 22302771
• Report Number: 2015691-2025-05056
• Device Sequence Number: 15476736
• Product Code: DYE
• UDI-Device Identifier: 00690103163582
• UDI-Public: (01)00690103163582(17)230309
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2025

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: 03/09/2023
• Device Model Number: 6900PTFX
• 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: 03/24/2025
• Initial Report FDA Received Date: 06/20/2025
• Date Device Manufactured: 03/10/2019
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Female