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

Model Number	2800TFX
Medical Device Problem Code	Thickening of Material (4056)
Health Effect - Clinical Codes	Asthma (1726); Chest Pain (1776)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Edwards received notification that a patient with a 2800tfx25 valve implanted in aortic position underwent a valve-in-valve intervention after an implant duration of nine (9) years and one (1) month due to leaflet thickening and stiff leaflet movement leading to severe regurgitation and moderate stenosis observed on cardiac ultrasound.During telephone follow-up with the patient, it was learned that the patient was hospitalized for chest tightness and asthma four (4) days before reintervention.A 29mm non edwards transcatheter valve was successfully implanted within the edwards surgical valve concomitantly with coronary artery graft (cag).Postoperative ultrasound showed that the transcatheter valve functioned normally.During the hospitalization, antiplatelet, lipid regulation and plaque stabilization, diuresis, improvement of cardiac function, hypoglycemia and symptomatic supportive treatment were given.The patient was discharged on postoperative day (pod)# 4.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: the device was not returned to edwards for further investigation, as the valve remained implanted due to a valve-in-valve replacement, and no images or medical records were provided.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Devices are typically explanted or disabled because they are not functioning optimally.In some cases, the failure mode is not provided.Other times, it may be reported as but not limited to; stenosis, increased/high gradient, regurgitation, transvalvular leak, thickened leaflet, leaflet tear, immobility, restriction, and/or unspecified svd or nsvd.Leaflet thickening may be attributed to structural valve deterioration (svd) and/or non-structural valve dysfunction (nsvd).Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.Structural valve deterioration (svd) can, and typically does, lead to chronic central leaks over a period of time.Svd is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Degeneration-related structural deterioration is most commonly related to patient factors and is not usually an indication of a device malfunction related to a manufacturing deficiency.Nsvd is defined as any abnormality not intrinsic to the valve itself that results in dysfunction of the prosthetic valve.The term nsvd refers to problems that are not directly related to failing valve components, yet it results in dysfunction of the prosthetic valve.There can be several causes of early leaflet thickening, such as early thrombosis/halt, early endocarditis or host tissue overgrowth.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.Based on the information available, the most likely root cause is patient factors, including hyperlipidemia and coronary artery disease.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 20062034
• Report Number: 2015691-2024-06432
• Device Sequence Number: 12851292
• Product Code: DYE
• UDI-Device Identifier: 00690103177251
• UDI-Public: (01)00690103177251(17)181018
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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: 10/18/2018
• 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: 08/01/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2014
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male