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

Model Number	6900PTFX33
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported and through medical records, a patient with a 33mm 6900ptfx mitral valve implanted in the tricuspid position for three (3) years, seven (7) months, underwent valve-in-valve procedure due to severe tricuspid regurgitation and stenosis.Patient presented with acute on chronic diastolic heart failure.Ttvr was successfully performed with a 29mm 9755rsl transcatheter valve with good result and no complications.Patient left room in stable condition.
Additional Manufacturer Narrative
The device was not returned to edwards for evaluation as it remains implanted.Edwards will continue to review and monitor all events.Trends are monitored on a the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
Additional Manufacturer Narrative
Added information to h6.Based on the information available, the device was intentionally used outside the way it was designed and intended.The performance, safety, efficacy, longevity, and durability of bioprosthetic valves have not been determined when the product is used outside the scope of its intended use and/or its studied population.Regurgitation identified post-procedurally has many potential root causes, including structural valve deterioration (svd), non-structural valve dysfunction (nsvd), endocarditis and/or thrombosis.Regurgitation occurring post-procedurally is most commonly related to patient and/or procedural factors and is not typically an indication of a device malfunction related to a manufacturing non-conformance.A device history record (dhr) review was performed, and no relevant non-conformances were identified.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 valve position and patient anatomy.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PLUS MITRAL PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LFIESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 22321234
• Report Number: 2015691-2025-05138
• Device Sequence Number: 15658214
• Product Code: DYE
• UDI-Device Identifier: 00690103163629
• UDI-Public: (01)00690103163629(17)250303
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 07/21/2025

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: 03/03/2025
• Device Model Number: 6900PTFX33
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2021
• 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: 27 YR
• Patient Sex: Female