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

Model Number 11500A29

Device Problems Degraded (1153); Patient Device Interaction Problem (4001)

Patient Problems Angina (1710); Insufficient Information (4580)

Event Date 10/17/2023

Event Type  Injury  

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 29mm 11500a inspiris valve underwent a redo aortic valve replacement procedure after an implant duration of 11 months due to pannus formation on top of the leaflet from stent to stent.The explanted valve was replaced with a 27mm 11060a aortic valved conduit.The patient was noted to be in recovery post procedure.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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.An engineering evaluation is not required because there is no allegation of a malfunction which could be related to a manufacturing non-conformance; no labeling non-conformance/deficiency; no use-related issue with a hazardous situation; no device-related infection; and there is 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 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.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

H3: evaluation summary: customer report of pannus formation was confirmed.The x-ray demonstrated the wireform and cocr band remained intact.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 12mm on leaflet 2 at the outflow aspect.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 6mm on leaflet 2 at the inflow aspect.Host tissue on the stent circumference was moderate at both the inflow and outflow aspects.As received, a section of host tissue approximately 21mm was attached near commissure 1 at the inflow aspect.Host tissue fused leaflets 1 and 2 by approximately 2mm at commissure 2, and leaflets 2 and 3 by approximately 3mm at commissure 3.Host tissue overgrowth restricted leaflet mobility and led to stenosis.A suture fastener and pledget remained attached to the sewing ring around leaflet 2.

Event Description

It was reported and learned through medical records that a patient with a 29mm 11500a inspiris valve underwent a redo aortic valve replacement procedure after an implant duration of 11 months and 16 days due to pannus formation on top of the leaflet from stent to stent with restricted leaflet motion, severe insufficiency and stenosis.The patient presented with chest pain.The explanted valve was replaced with a 27mm 11060a aortic valved conduit.The patient was noted to be doing fine and in recovery post procedure.Per medical records: the patient presented with chest pain several months after surgery, a ct showed a significant change in his aortic root size recent cardiac cath showed 80% lesion in lad.Preoperative diagnosis, angina with cad, aortic root aneurysm, and severe bioprosthetic aortic valvular insufficiency.Intraoperatively, very dense adhesions were found around the old ascending graft especially along the right atrium.The 29mm inspiris valve was found to have pannus ingrowth on the leaflet near the rca, the pannus ingrowth went on the aortic side halfway up the leaflet, restricting leaflet motion and causing aortic insufficiency.The patients tissue noted as scarred and fibrotic.The patient did not want a mechanical valve, so it was decided to replace the aortic root with a 27mm 11060a avc, coronary reimplantation, graft to graft anastomosis and cabg x1 to the lad.Suture was placed outside the aorta to limit any foreign tissue inside the aorta that might induce more pannus growth.Post cpb the bioprosthetic valve was functioning normally, with a mean gradient of 8mmhg.The patient tolerated the procedure well.Per information received the patient is described as healthy and a triathlete, coronaries were fine a year ago, now 80-90% block.The patient required an aortic root replacement due to a 5.3cm aortic aneurysm and cabg.The explanted 29mm 11500a was covered in pannus on the top of the leaflet from stent post to stent post with not much to report underneath.

Manufacturer Narrative

H10: additional manufacturer narrative: updated: b4, b5, b7, g3, g6, h2, h6.

Manufacturer Narrative

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 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.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.

• 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: 18111933
• MDR Text Key: 327882037
• Report Number: 2015691-2023-17405
• 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,Followup
• Report Date: 03/28/2024

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
• Device Model Number: 11500A29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 12/06/2023; 01/25/2024; 01/23/2024; 03/27/2024
• Supplement Dates FDA Received: 12/21/2023; 02/16/2024; 02/21/2024; 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 55 YR
• Patient Sex: Male