MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11500A25

Device Problems Calcified (1077); Patient Device Interaction Problem (4001); Device Stenosis (4066)

Patient Problems Atrial Fibrillation (1729); Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)

Event Date 11/21/2023

Event Type  Injury  

Manufacturer Narrative

H10: additional manufacturer narrative: 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 Description

It was reported that a patient with a 25mm 11500a inspiris valve underwent a redo aortic valve replacement procedure after an implant duration of two (2) years, eight (8) months due to aortic stenosis.The patient presented with atrial fibrillation and was on eliquis.The explanted valve was replaced with a 25mm non-edwards mechanical valve.The patient was noted to be stable post procedure.

Manufacturer Narrative

H10: additional manufacturer narrative: h3: evaluation summary: customer report of stenosis was unable to be confirmed due to valve condition as received.Three leaflet fragments were received detached from the valve and were unable to be matched up to the returned valve.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.X-ray also demonstrated heavy calcification on all three leaflet fragments and the remainder of the leaflets on the returned valve.Host tissue overgrowth on the stent circumference was moderate at the inflow aspect and minimal on the outflow aspect.Sewing ring was cut off in multiple areas around the valve and cut off sewing ring fragments were not returned.Wireform was exposed on commissure 1 and around leaflet 1 on the outflow aspect.The metal band was exposed around leaflet 3 on the inflow aspect.

Event Description

It was reported and learned through medical records that a patient with a 25mm 11500a inspiris valve in aortic position underwent a redo aortic valve replacement procedure after an implant duration of two (2) years, six (6) months and 4 days due to aortic stenosis.The patient presented with worsening shortness of breath and heart failure.The explanted valve was replaced with a 25mm non-edwards mechanical valve.The patient tolerated the procedure well and was noted to be stable post procedure.The patient was discharged on pod #7.Per medical records the patient underwent redo avr with annular root enlargement with patch and laa ligation product evaluation demonstrated heavy calcification on all 3 leaflet fragments and the remainder of the leaflets on the returned valve.Host tissue overgrowth on the stent circumference was moderate at the inflow aspect and minimal on the outflow aspect.

Manufacturer Narrative

Calcific degeneration is a common cause of bioprosthetic heart valve failures.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valve's hemodynamic performance, and glutaraldehyde fixation of tissue.Of these, the fixation process is a relatively minor contributor to calcification for edwards' tissue valves due to anti-calcification treatments during manufacturing.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent bioprostheses from calcifying.Calcification is most commonly related to patient factors and is not usually an indication of a device malfunction related to a manufacturing deficiency.An engineering evaluation is not required because 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 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 are no confirmed product or labeling non-conformances and no other triggers are met.The most likely cause is patient factors, including coronary artery disease and hyperlipidemia.Pannus overgrowth, or host tissue, is considered a form of non-structural valve dysfunction.The growth of host tissue on the sewing ring is expected and is a natural part of the healing reaction to prosthesis implantation.In contrast, if there is an excessive amount of pannus growth, it can extend onto the cusp surfaces leading to thickening of the cusps, leaflet immobility, elevated gradients, and stenosis.Host tissue growth can also contribute to cusp retraction or curling resulting in valvular regurgitation.Host fibrous (pannus) tissue growth is not a malfunction of the device related to a manufacturing deficiency.An engineering evaluation is not required because 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 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 are no confirmed product or labeling non-conformances and no other triggers are met.The most likely cause is patient factors.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18338558
• MDR Text Key: 330625198
• Report Number: 2015691-2023-18431
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 11500A25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male