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

Model Number	3000TFX
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Dyspnea (1816); Swelling/ Edema (4577)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported and learned through investigation that a 21mm 3000tfx aortic valve in aortic position was disabled via valve in valve procedure after an implant duration of seven (7) years, 7 months due to severe aortic stenosis.The patient presented with heart failure symptoms including dyspnea, fatigue, and lower extremity edema.Tavr was completed with a 23mm 9755rsl transcatheter valve without procedural complications.The patient was stable and was discharged on pod# 3.Per medical record, tte showed ef of 50%, bioprosthetic aortic valve with moderate to severe regurgitation, mildly elevated pulmonary pressures, mitral annular calcification, thickening, mild regurgitation and mild tricuspid valve regurgitation.
Additional Manufacturer Narrative
H11: 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: stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potentials known and unknown patient-related contributing factors.Per technical summary 33069, rev a, structural valve deterioration (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, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, non-structural valve dysfunction (nsvd) may also play a role in the development of valvular stenosis.Stenosis is most commonly related to patient factors and is not usually an indication of a device malfunction related to a manufacturing deficiency.Devices implanted 5 years or greater with calcification, dehiscence, leaflet tears, thickened leaflet, pannus, or structural valve deterioration (stenosis, regurgitation) reported as the complaint do not require an engineering evaluation.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 capa/scar/pra is not required, as there is no confirmed product, or labeling non-conformances and no other triggers are met.The most likely cause is patient factors, including hyperlipidemia (hld) and coronary artery disease (cad).All pertinent information available to edwards lifesciences has been submitted.

• 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: 19212428
• Report Number: 2015691-2024-03225
• Device Sequence Number: 8105768
• Product Code: DYE
• UDI-Device Identifier: 00690103163643
• UDI-Public: (01)00690103163643(17)200212
• 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: 2016
• 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
• Report Date (Section B): 05/31/2024

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: 02/12/2020
• 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: 04/05/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2016
• 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: 79 YR
• Patient Sex: Female