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

Model Number	3000TFX
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a 19mm 3000tfx aortic valve in aortic position is under evaluation for a possible valve in valve procedure after an implant duration of 6 years, 5 months due to regurgitation.
Additional Manufacturer Narrative
The subject device is not available for evaluation, as it remains implanted in the patient.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 sections: b4, g3, g6, h2, h6 (type of investigation, investigation findings, and investigation conclusions).The device history record (dhr) review was completed, and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Engineering evaluation summary: per doc-0249230, regurgitation identified post-procedurally has many potential root causes, including structural valve deterioration (svd), non-structural valve dysfunction (nsvd), endocarditis and/or thrombosis.Regurgitation occurring during device implantation or post-procedurally is most commonly related to patient and/or procedural factors and is not typically an indication of a device malfunction related to a manufacturing non-conformance.A definitive root cause is unable to be determined, however, patient and/or procedural factors likely caused or contributed.All pertinent information available to edwards lifesciences has been submitted.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections: b4, b5, b7, g3, g6, h2, h6 (clinical code, type of investigation, and investigation conclusions).Engineering evaluation summary: the most likely root cause is patient-related factors, including hyperlipidemia (hld), diabetes mellitus (dm), coronary artery disease (cad).All pertinent information available to edwards lifesciences has been submitted.
Event or Problem Description
It was reported and learned through investigation that a patient with a 19mm 3000tfx aortic valve in aortic position is under evaluation for a valve in valve procedure after an implant duration of six (6) years, five (5) months due to regurgitation.The patient presented with heart failure and shortness of breath.
Event or Problem Description
It was reported and learned through investigation that a patient with a 19mm 3000tfx aortic valve in aortic position underwent a valve replacement procedure after an implant duration of six (6) years, 10 months due to regurgitation.The patient presented with heart failure and shortness of breath.Avr was completed with a 21mm 11500a aortic valve.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections: b2 - b5, d6, g3, g6, h2, h6.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 19937295
• Report Number: 2015691-2024-05957
• Device Sequence Number: 20056353
• Product Code: DYE
• UDI-Device Identifier: 00690103163636
• UDI-Public: (01)00690103163636(17)200307
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/31/2025

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: 03/07/2020
• Device Model Number: 3000TFX
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 07/14/2024
• Supplement Date Received by Manufacturer: 09/12/2024; 09/16/2024; 01/07/2025
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 09/16/2024; 09/17/2024; 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2016
• 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: Life Threatening; Other; Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female