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

Model Number 11500A

Device Problems Calcified (1077); Gradient Increase (1270); Difficult to Open or Close (2921); Patient Device Interaction Problem (4001); Thickening of Material (4056)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2023

Event Type  Injury  

Manufacturer Narrative

H10: 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 Description

Edwards received notification that a 49-year-old patient with a 21mm inspiris valve implanted in the aortic position was scheduled for a re-do intervention after an implant duration of two (2) years and four (4) months due to calcification leading to severe stenosis (peak/mean gradient 70/42mmhg) with thickened and poorly mobile leaflets.Reportedly, the patient did not have any signs or symptoms.The patient was discharged home and waiting for re-intervention.Indication for initial surgery was endocarditis on aortic and tricuspid position.Avr and tricuspid valve plasty were performed concomitantly.Last echo revealed small mitral native leaflet prolapse leading to mild insufficiency and tricuspid insufficiency grade 2+/4+.

Event Description

Edwards received notification that a 49-year-old patient with an inspiris valve model 11500a21 implanted in the aortic position was scheduled for a re-do intervention after an implant duration of two (2) years and four (4) months due to calcification leading to moderate stenosis (peak/mean gradient 70/42mmhg) with thickened and poorly mobile leaflets.Reportedly, the patient was asymptomatic.A 23mm non-edwards mechanical valve was successfully implanted in replacement with no reported complication.Reportedly, when the valve was explanted, the valve looked fine and no calcification was observed.Thus, the physicians suspected that the root cause of the moderate stenosis was patient prosthesis mismatch (ppm).The patient was noted as to be in stable condition.Indication for initial surgery was endocarditis on aortic and tricuspid position.Avr and tricuspid valve plasty were performed concomitantly.Last echo revealed small mitral native leaflet prolapse leading to mild insufficiency and tricuspid insufficiency grade 2+/4+.However, tricuspid and mitral valve were not treated during reintervention.

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.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.

Manufacturer Narrative

Corrected data h6 (device code): "1077 - calcified" code removed, h6 (type of investigation): "4117 - device not accessible for testing" code removed.H3: evaluation summary customer report of calcification, stenosis and thickened leaflets were unable to be confirmed through visual observations.As received, commissure 2 was bent outwards.X-ray demonstrated cocr band was intact and the vfit cocr alloy band was not expanded.Moderate host tissue overgrowth encroached onto the leaflet and into the orifice on the inflow aspect.Host tissue on the stent circumference was moderate at the inflow aspect and heavy at the outflow aspect.Mechanical damage marks were observed on the free margin of leaflet 2 near commissures 2 and 3.Damages appeared serrated and did not penetrate leaflets.Wireform was exposed on commissures 1 and 2.Sewing ring was cut in multiple areas around the valve.Metal band was exposed around all three leaflets on the inflow aspect.H10: additional manufacturer narrative: pannus overgrowth, or host tissue, is considered to be 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.A small amount of host tissue growth over the suture line is needed to form a non-thrombogenic surface and complete the healing process after valve 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 regards 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: 18015555
• MDR Text Key: 326648692
• Report Number: 2015691-2023-17085
• 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: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2022
• 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: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2020
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 84 KG