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

Model Number	3300TFX
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	08/26/2025
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 and through investigation that a patient with a 27mm 3300tfx aortic valve implanted in the pulmonic position underwent a valve-in-valve procedure after an implant duration of 7 years, 9 months due to moderate insufficiency and mild-moderate stenosis.The patient presented with shortness of breath.The procedure was performed successfully with a 29mm 9755rsl transcatheter valve.The patient was in stable condition post procedure and was discharged on pod#1.
Additional Manufacturer Narrative
Updated sections: g3, g6, h6 type of investigation, investigation findings, and investigation conclusions.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 is a common manifestation of bioprosthetic valve and valved conduit dysfunction.Common intraoperative factors that may cause or contribute to acute post-procedural regurgitation include device distortion; device interaction with patient anatomy or other devices; leaflet damage, and incorrectly sized valve seated.Non-structural valve dysfunction (nsvd), endocarditis and/or thrombosis may also cause or contribute to acute post-procedural regurgitation.Complaints reported with regurgitation as the primary complaint code are not typically attributed to manufacturing-related nonconformances.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 patient age at implant.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA 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: 23100231
• Report Number: 2015691-2025-07740
• Device Sequence Number: 8617648
• Product Code: DYE
• UDI-Device Identifier: 00690103176162
• UDI-Public: (01)00690103176162(17)201202
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Report Date (Section B): 10/30/2025

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: 12/02/2020
• Device Model Number: 3300TFX
• 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: 08/26/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2016
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 20 YR
• Patient Sex: Male