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

Model Number 11500A

Device Problems Gradient Increase (1270); Difficult to Open or Close (2921); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

H10: additional narratives: surgical/percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.The device was returned and product evaluation 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.

Event Description

Edwards received information that a patient with a 21mm 11500aj pericardial aortic valve, implanted four (4) years and four (4) months, was explanted due to aortic stenosis secondary to restriction of leaflet mobility caused by pannus overgrowth.Elevated pressure gradient was also seen.The device was explanted and replaced with the same size and model 21mm 11500aj pericardial aortic valve with no patient adverse event reported.The patient status was reported as recovered.Upon the device explant, pannus overgrowth was seen on the inflow side of the device.

Manufacturer Narrative

H10: additional narratives h3: product evaluation.Customer reports of stenosis, restricted leaflet mobility, and pannus were confirmed.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.Heavy host tissue overgrowth formed a ring on the surface of the leaflets at the inflow aspect and encroached onto the tissue and into the orifice at the greatest distance of approximately 9mm on leaflet 3 at the inflow aspect.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 8mm on leaflet 1 at the outflow aspect.Host tissue overgrowth fused leaflets 1 and 3 by approximately 3mm at commissure 1 and leaflets 2 and 3 by approximately 2mm at commissure 2 on the outflow aspect.Host tissue overgrowth on the stent circumference was moderate at both the inflow and outflow aspects.Host tissue overgrowth restricted leaflet mobility and led to stenosis.Sewing ring was cut around leaflet 2.The metal band was exposed around leaflets 1 and 3 on the inflow aspect.Multiple sutures remained attached to the sewing ring around the valve.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections: b4, d4, g3, g6, h2, h4, 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: per drm doc-0105049, rev d, 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.The most likely cause is patient factors.All pertinent information available to edwards lifesciences has been submitted.

• 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 ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17101462
• MDR Text Key: 316937643
• Report Number: 2015691-2023-13585
• 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: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2020
• Device Model Number: 11500A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2018
• 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; Life Threatening; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female