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

Model Number 11500A

Device Problems Fluid/Blood Leak (1250); Gradient Increase (1270); Difficult to Open or Close (2921); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

H10: additional 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

Edwards received notification that a young patient with an inspiris valve model 11500 implanted in an unknown position underwent a re-do intervention after approximately 2 years for unknown reason.No other information was provided.

Event Description

Edwards received notification that a young patient around 29 years with an inspiris valve model 1150021 implanted in the aortic position underwent redo surgery for valve explant after an implant duration of two (2) years and six (6) months due to stiffness and inflexibility of one of the leaflets leading to stenosis (peak/mean gradient 77/41 mmhg; velocity 4.4 m/sec) and moderate transvalvular regurgitation.The patient presented with dyspnea on exertion.A non-edwards mechanical valve was implanted in replacement.The patient was noted as to be discharged home.

Manufacturer Narrative

H10: additional manufacturer narrative: 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.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.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.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.A definitive root cause cannot be conclusively determined, however, patient factors likely caused or contributed.

Manufacturer Narrative

Added information to section d9 (device availability) and date returned to manufacturer.Updated section b4 (date of this report), g3 (date received by manufacturer), h6 (device code), h6 (type of investigation) and h6 (investigations conclusions).H3.Device evaluation: the device was returned for evaluation.Customer report of stenosis was confirmed through observed host tissue overgrowth.Report of regurgitation was confirmed through observed rolled leaflets due to host tissue overgrowth.Heavy host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 10mm on leaflet 2 at inflow aspect.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 4mm on leaflet 2 at the outflow aspect.The free margins of leaflets 1 and 2 were rolled towards the outflow aspect from host tissue overgrowth and created a gap in the central coaptation region.Leaflet 1 also had host tissue overgrowth pulling the free margin from the inflow aspect.Host tissue overgrowth on the stent circumference was moderate at both the inflow and outflow aspects and fused leaflets 2 and 3 by approximately 4 mm at commissure 3 on the outflow aspect.Host tissue overgrowth restricted leaflet mobility and led to stenosis.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.X-ray also demonstrated minimal calcification on leaflet 1.Multiple suture threads remained attached to the sewing ring.Metal band was exposed around all three leaflets on the inflow aspect.H10: additional manufacturer narrative: 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.Echo images and videos were received and assessed by an independent expert in echocardiography.Per image review, the pattern of leaflet thickening (exaggerated toward the commissural edges more so than the leaflet bases) is not suggestive of typical structural valve degeneration.Because the degree of reduced systolic leaflet opening does not appear to be severe, and because the trans-aortic acceleration time is not prolonged, it is possible or probable that factors other than prosthetic stenosis are contributing to elevated gradients.These factors likely include high transvalvular flow in part attributable to ar and potentially in part attributable to hyperdynamic lv systolic function.In the setting of a non-dilated aortic root, pressure recovery also could be contributing to high gradients potentially out of proportion to the severity of valvular stenosis.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.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.The most likely cause is patient factors.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 18387095
• MDR Text Key: 331290598
• Report Number: 2015691-2023-18737
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2022
• Device Model Number: 11500A
• 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: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 77 KG