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

Model Number	3300TFX
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a 25mm 3300tfx aortic valve underwent a valve-in-valve procedure after an implant duration of 11 years, 3 months due to moderate calcification and critical stenosis.The patient presented with symptoms of heart failure.The tavr and surgical leaflet modification was successfully performed with a 23mm 9755rsl valve.The patient was discharged home on pod #1.Per medical records, the patient presented to the hospital with acute systolic chf.Heart cath showed, moderately thicken and calcified aortic valve leaflets with critical aortic stenosis.Patient was worked up for pci/tavr and was transferred to another hospital for tavr procedure; cardiologist decided to perform a pci/stent ((b)(6) 2026) and discharged patient home.Tavr/viv was performed 8 days later.
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.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated: g6, h2, h6: (investigation findings, investigation conclusions).The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency and/or one was not confirmed through investigation.Svd is an acquired condition, intrinsic to bioprosthetic valves, characterized by deterioration of the leaflets or supporting structures, leading to thickening, calcification, tearing, or disruption of the prosthetic valve materials.These changes result in valvular dysfunction manifesting as stenosis and/or regurgitation with a consequent drop in hemodynamic efficacy of the valve.Svd commonly occurs with a considerably increased rate after 10 years.Prior investigations and extensive literature review have shown that it is predominantly related to patient factors and implant duration rather than to manufacturing issues.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.Based on the information available, the most likely cause is patient factors, including an implant duration of 10 or more years.

• 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: jason reves ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492503859
• MDR Report Key: 24547046
• Report Number: 2015691-2026-12665
• Device Sequence Number: 13132978
• Product Code: DYE
• UDI-Device Identifier: 00690103176155
• UDI-Public: (01)00690103176155(17)180503(11)140504
• 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: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: 05/03/2018
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2014
• 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: 69 YR
• Patient Sex: Male