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

Model Number	3300TFX
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: this report serves as both the initial and final medical device report (mdr), incorporating the findings from the investigation.The subject device is not available for evaluation as it remains implanted in the patient.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.Structural valve deterioration (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.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
Per the report received from the united kingdom, edwards received notification that this patient with a 3300tfx19mm valve implanted in the aortic position underwent a valve-in-valve procedure after an implant duration of fourteen (14) years and nine (9) months due to degeneration.The patient presented with dyspnea and occasional dizziness and jaw pain before the reintervention.A transcatheter valve was successfully implanted within the edwards surgical valve.The patient had a right bundle branch block (bbbb) with left hemiblock pre-procedure, and a complete heart block (chb) post-procedure, needing a pacemaker.The patient was noted as to be in stable condition.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jason reves ; one edwards way; irvine, CA 92614 ; 9492503859
• MDR Report Key: 24257941
• Report Number: 2015691-2026-10788
• Device Sequence Number: 15447732
• Product Code: DYE
• UDI-Device Identifier: 00690103176124
• UDI-Public: (01)00690103176124(17)150126
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: 01/26/2015
• 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: 01/19/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female