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

Model Number	3000TFX
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via the implant patient registry and learned through investigation that a 25mm 3000tfx aortic valve was explanted after an implant duration of 9 years, 3 months due to regurgitation.The patient presented with lower extremity edema and tachycardia.The explanted device was replaced with a 27mm 11500a valve.The patient was stable post-procedure and was discharged on pod #13.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 subject device is not available for evaluation, as it was discarded on-site.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
H10: additional manufacturer narrative: updated sections: d4 (expiration date), g3, g6, h2, h4, h6 (type of investigation, investigation findings, and investigation conclusions).Regurgitation is a common manifestation of bioprosthetic valve and valved conduit dysfunction.Common intraoperative factors that may cause or contribute to acute post-procedural regurgitation include device distortion; device interaction with patient anatomy or other devices; leaflet damage, and incorrectly sized valve seated.Non-structural valve dysfunction (nsvd), endocarditis and/or thrombosis may also cause or contribute to acute post-procedural regurgitation.Complaints reported with regurgitation as the primary complaint code are not typically attributed to manufacturing-related nonconformances.A device history record (dhr) review was performed, and no relevant non-conformances were identified.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.Based on the information available, the most likely root cause is patient factors, including coronary artery disease (cad).

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA 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: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 23623696
• Report Number: 2015691-2025-09495
• Device Sequence Number: 13280120
• Product Code: DYE
• UDI-Device Identifier: 00690103163667
• UDI-Public: (01)00690103163667(17)190311
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: 03/11/2019
• Device Model Number: 3000TFX
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2015
• 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: 67 YR
• Patient Sex: Male