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

Model Number	2800TFX
Medical Device Problem Codes	Difficult to Open or Close (2921); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fatigue (1849); Insufficient Information (4580)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
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 learned through implant patient registry that a patient with a 25mm 2800ftx aortic valve, was explanted after an implant duration of three (3) years, seven (7) months due to unknown reason.The explanted valve was replaced with a 23mm 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: updated sections: b5, b7, g3, g6, h2, h6 (component code, clinical code, device code, type of investigation).Due diligence attempts have been made to obtain the status of the explanted device for return.At this time, the device has not been provided.
Event or Problem Description
It was learned through implant patient registry and investigation that a patient with a 25mm 2800tfx aortic valve, was explanted after an implant duration of three (3) years, seven (7) months due to severe insufficiency and stiff leaflets.The explanted valve was replaced with a 23mm 3300tfx valve.Per medical records, the patient developed recent fatigue and echo showed severe aortic insufficiency.Ct showed disruption of proximal end of previously placed graft with large pseudoaneurysm.The patient underwent redo avr and graft replacement.Intraoperatively, the pseudoaneurysm was found to extend from the proximal end of the graft/ventricular cavity and extended up to the point where graft attached to the proximal arch of the aorta.The entire graft and prosthetic valve were removed, leaflets were functional but stiff.A 23mm 3300tfx valve was sewn into a new 24mm valsalva conduit.It was noted there was no discernible annulus, so the graft was attached to the distal lvot.After hemostasis was achieved, the patient was transferred to the icu in guarded condition, and discharged on pod #20.
Additional Manufacturer Narrative
Leaflet immobility or leaflet restriction occurring over time, and not due to extrinsic physical interference, is a form of structural valve deterioration, which can result in significant regurgitation and/or stenosis.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.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.The instructions for use (ifu) have been reviewed, and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.A dhr review was performed, and no related manufacturing nonconformances were identified.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 use-related issue with a hazardous situation; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.The most likely cause is patient factors.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON 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: 21454189
• Report Number: 2015691-2025-01282
• Device Sequence Number: 12684337
• Product Code: DYE
• UDI-Device Identifier: 00690103194104
• UDI-Public: (01)00690103194104(17)250218
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 04/01/2025

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: 02/18/2025
• Device Model Number: 2800TFX
• 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: 01/31/2025
• Supplement Date Received by Manufacturer: 02/25/2025; 03/24/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/20/2025; 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2021
• 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