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

Model Number	3300TFX
Medical Device Problem Codes	Perivalvular Leak (1457); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); Hemodynamic instability (4868)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via the implant patient registry that a patient with a 23mm 3300tfx aortic valve was explanted after an implant duration of 7 days due to unknown reason.The explanted valve was replaced with a 21mm 3300tfx valve.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: the device was not returned for evaluation, as the device request is ongoing.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 via the implant patient registry and investigation that a patient with a 23mm 3300tfx aortic valve was explanted after an implant duration of 7 days due to moderate to severe perivalvular leak.The explanted valve was replaced with a 21mm 3300tfx valve.Patient was transferred to the cardiovascular icu and hemodynamic stable but critical condition.Post-op cardiogenic shock requiring mcs.Per medical records, the patient is s/p ave, mvr and cabg x1 7 days ago.During previous procedure, it was noted that significant amount of calcification was seen at the base of the aortic valve annulus and extending into the aorta mitral curtain and there was significant circumferential mac involving the mitral valve as well.Additionally, core knot device was used to tie the valve sutures down back then.Patient did require cardiopulmonary support using va ecmo for few days plus intra-aortic balloon pump placement which have been removed before this reintervention.The patient was brought back to the or for redo avr.Intraoperatively, the valve appeared to be competent, however, all sutures appeared to be loosened at the base of the left coronary cusp annulus.The 23mm 3300tfx aortic valve was removed and a 21mm 3300tfx valve was implanted in replacement.Post operatively, the patient was transferred to the cardiovascular icu and hemodynamic stable but critical condition and on ecmo support.
Additional Manufacturer Narrative
Updated sections: b5, b7, g3, g6, h2, h6 health effect - clinical code, device code(s), and type of investigation.

• 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jason reves ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492503859
• MDR Report Key: 24750076
• Report Number: 2015691-2026-13728
• Device Sequence Number: 13315790
• Product Code: DYE
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2026

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 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: 03/06/2026
• Supplement Date Received by Manufacturer: 03/20/2026; 04/16/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/15/2026; 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2025
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male