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

Model Number	2700TFX
Medical Device Problem Codes	Calcified (1077); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via the implant patient registry that a patient with a 27mm 2700tfx aortic valve was explanted after an implant duration of 9 years, 3 months due to unknown reason.The explanted valve was replaced with a 2mm 11500a 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
H11: additional manufacturer narrative: the subject device is not available for evaluation, as it has been discarded.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated sections: d4 (expiration date), g3, g6, h2, h4, h6 (investigation findings, and investigation conclusions).Svd is a logical and expected consequence of the chemical, mechanical, and immunological processes associated with bhv implantation.The common endpoint of all these factors is calcification and degradation.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.Despite the advancements in the heart valve industry, svd commonly begins 7- 8 years after implantation, with a considerably increased rate in patients with pertinent comorbidities and/or an implant duration of greater than 10 years.Prior investigations and extensive literature review have shown that svd is predominantly related to patient factors and implant duration rather than to manufacturing issues.Events related to device design, manufacturing, or use error tend to manifest at an earlier implant duration.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 an implant duration of 7 or more years.
Event or Problem Description
It was reported via the implant patient registry and learned through investigation that a patient with a 27mm 2700tfx aortic valve was explanted after an implant duration of 9 years, 3 months due to calcification and degeneration.The explanted valve was replaced with a 27mm 11500a valve.Per medical records, the patient presented with leaflets calcification, structural valve degeneration, with a hole in the r leaflet manifested as severe bioprosthetic valve regurgitation and stenosis.The patient underwent a redo avr and cabg x2 in the same procedure.The valve was removed and replaced with a 27mm 11500a valve.Postoperative echo showed well-seated valve with no paravalvular leak, and the patient tolerated the procedure well with no immediate complications.On pod# 5, the patient was discharged.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated sections: b5, b7, g3, g6, h2, h6 (type of investigation).

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON 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: jason reves ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492503859
• MDR Report Key: 23952314
• Report Number: 2015691-2026-10168
• Device Sequence Number: 10725076
• Product Code: DYE
• UDI-Device Identifier: 00690103194050
• UDI-Public: (01)00690103194050(17)200411
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2026

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: 04/11/2020
• Device Model Number: 2700TFX
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 12/30/2025; 01/31/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 01/21/2026; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2016
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male