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

Model Number	7300TFX
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: 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
It was reported and learned through medical records that a patient with a 29mm 7300tfx mitral valve is under evaluation for a valve-in-valve procedure after an implant duration of 13 years, 7 months due to structural valve deterioration and severe mitral stenosis.The patient presented with nyha class iii iv heart failure , shortness of breath with minimal activity, progressive fatigue, lower extremity edema.Per medical records, pre op tte demonstrated mean gradient up to 13.5 mmhg, trivial mitral regurgitation, severe tricuspid regurgitation, right ventricular systolic pressure 80 mmhg, ejection fraction 70%, and ascending aorta 46 mm.The patient underwent induction for transcatheter mitral valve replacement, however developed cardiogenic shock with decompensated right heart failure, followed by pea arrest requiring cpr and epinephrine and ventricular tachycardia treated with amiodarone.Tee demonstrated severe rv dysfunction and bilateral pleural effusions.The procedure was aborted due to decompensation on induction of anesthesia.Post procedurally, the patient developed acute hypoxemic respiratory failure, bilateral pleural effusions requiring thoracostomy with greater 3 l output, right pneumothorax, and chest wall trauma following cpr, requiring mechanical ventilation with vasopressor and inotropic support.The hospital course was complicated by cirrhosis with ascites, chronic renal insufficiency with acute worsening, anemia requiring transfusion, cellulitis, and persistent cardiogenic shock.At the time of documentation, the patient remained in icu, intubated, on vasopressor and inotropic support, with goals of care discussion and dnr status consistent with patient wishes.This is an 82-year-old male patient.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: jason reves ; 1 edwards way; mle fl2; irvine, CA 92614 ; 9492503859
• MDR Report Key: 25568237
• Report Number: 2015691-2026-16192
• Device Sequence Number: 10249864
• Product Code: DYE
• UDI-Device Identifier: 00690103186277
• UDI-Public: (01)00690103186277(17)130930
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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: 09/30/2013
• Device Model Number: 7300TFX
• 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: 06/12/2026
• Initial Report FDA Received Date: 06/19/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male