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

Model Number	2700TFX25MM
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: 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 that a patient with a 25mm 2700tfx pericardial aortic valve underwent valve-in-valve intervention after an implant duration of eight (8) years, two (2) months due to aortic stenosis and regurgitation.The patient presented with heart failure and stage 3 chronic kidney disease.The tavr procedure was successfully performed with a 26mm 9755rsl transcatheter valve.
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 (hld), chronic kidney disease (ckd).The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON 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; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 21952356
• Report Number: 2015691-2025-03483
• Device Sequence Number: 18276500
• Product Code: DYE
• UDI-Device Identifier: 00690103194043
• UDI-Public: (01)00690103194043(17)201115
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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
• Device Expiration Date: 11/15/2020
• Device Model Number: 2700TFX25MM
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 06/10/2025
• Date Device Manufactured: 11/16/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Male