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

Model Number	3300TFX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	12/09/2025
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 21mm 3300tfx aortic valve was undergoing valve-in-valve procedure after an implant duration of 12 years, 4 months due to ppm with "abnormal leaflet mobility", when patient crashed requiring cpr and was converted to open heart surgery.Patient presented with heart failure.Per information received, patient was undergoing basilica procedure when patient's blood pressure dropped with low rv function.Anesthesia attempted stabilizing the patient, but the patient went into arrest, requiring cpr.Effusion was noted on echo and pericardiocentesis was attempted but unsuccessful.Patient was placed on ecmo and ct surgeons opened chest to control bleeding.Unfortunately, the surgeons were unable to repair bleeding noted from aortic annulus and patient expired the same day.The transcatheter valve never entered the patient and was wasted.This is a 70-year-old female patient.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections: g3, g6, h2.Corrected sections : h6 ( impact code, investigation findings and investigation conclusions) patient prosthesis mismatch (ppm) is present when the effective orifice area of the implanted bioprosthetic valve is too small in relation to body size.Literature indicates ppm is main hemodynamic consequence is to generate higher than expected gradients through a normally functioning bioprosthetic valve.It has been shown to be associated with worse hemodynamic function, less regression of left ventricular hypertrophy, more cardiac events, and lower survival.Improperly sized valves with ppm can hasten the development of early degenerative changes and premature prosthetic valve dysfunction with varying degrees of prosthetic valve stenosis and regurgitation.Although ppm is a well-recognized phenomenon of bioprosthetic valves, it is most likely related to patient anatomical changes after long implant durations.When discovered intraoperatively or early post-operatively, ppm is most likely related to procedural factors, including specific patient assessment and valve model and size selection.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.The most likely root cause is patient factors.A device history record (dhr) review is not performed because there is no allegation of a malfunction which could be related to a manufacturing non-conformance and/or one was not suspected or confirmed through investigation; no labeling non-conformance/deficiency; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.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.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC 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: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 23930767
• Report Number: 2015691-2025-10630
• Device Sequence Number: 18370073
• Product Code: DYE
• UDI-Device Identifier: 00690103176131
• UDI-Public: (01)00690103176131(17)170404
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2026

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: 04/04/2017
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/31/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/08/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female