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

Model Number	2700TFX
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient with a 25mm 2700tfx implanted five (5) years, 10 months, underwent valve-in-valve procedure due to aortic regurgitation.Tavr was successfully performed with a 26mm 9755rsl transcatheter valve.
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 b5, b7, h6.
Event or Problem Description
It was reported a patient with a 25mm 2700tfx implanted five (5) years, 10 months, underwent valve-in-valve procedure due to aortic regurgitation.Patient presented with heart failure, shortness of breath, and chest pain.Tavr was successfully performed with a 26mm 9755rsl transcatheter valve.Patient was stable at the end of the procedure.
Additional Manufacturer Narrative
Added information to h6.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, [for valves implanted in the mitral position: suture looping/leaflet entrapment by native tissue,] 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 diabetes mellitus.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 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: 22177740
• Report Number: 2015691-2025-04732
• Device Sequence Number: 18521703
• Product Code: DYE
• UDI-Device Identifier: 00690103194043
• UDI-Public: (01)00690103194043(17)230209
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2025

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
• Device Expiration Date: 02/09/2023
• Device Model Number: 2700TFX
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 06/19/2025; 07/17/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/14/2025; 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2019
• 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: 76 YR
• Patient Sex: Male