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

Model Number ASKU

Device Problems Calcified (1077); Degraded (1153); Gradient Increase (1270); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 11/28/2022

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 learned that a 19mm 11500a valve was explanted after an implant duration of 4 years, 3 months due to deterioration and pannus ingrowth.The explanted valve was replaced with a 25mm inspiris valve.

Manufacturer Narrative

H3: evaluation summary: customer reports of stenosis, structural valve deterioration, pannus overgrowth, and calcification were confirmed.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 leaflets.All three leaflets had extrinsic calcific deposits along the free margins on the outflow aspect.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 6mm on leaflet 3 at the inflow aspect.Host tissue overgrowth on the stent circumference was moderate at the outflow aspect.Calcification and host tissue overgrowth restricted leaflet mobility and led to stenosis.Sewing ring was cut around leaflet 1 and commissure 3.Metal band was exposed around multiple areas around the valve on the inflow aspect.Wireform was exposed on commissure 3.

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.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.Pannus can have both beneficial and harmful effects depending on the amount of growth.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.Calcification is most commonly related to patient factors and is not usually an indication of a device malfunction.Host fibrous (pannus) tissue growth is not a malfunction of the device.The root cause of this event was determined to be due to patient related factors.The event observed in this case was due to a progression of the patient's underlying valvular disease pathology combined with the patient's other underlying risk factors, including coronary artery disease (cad), history of coronary artery bypass graft (cabg), bicuspid aortic valve, diabetes mellitus (dm) and hyperlipidemia (hld).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.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

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

Event Description

It was learned that a 19mm 11500a valve was explanted after an implant duration of 4 years, 3 months due to severe as, structural valve deterioration and pannus overgrowth.Later, pathology report revealed leaflets calcification along with the pannus overgrowth.The explanted valve was replaced with a 25mm 11500a aortic valve.The patient underwent avr utilizing a 25mm 11500a aortic valve, aortic root enlargement with non-edwards bovine pericardial patch, and cabg 1x.The patient tolerated the procedure well without complications.Post-bypass echo shows well-seated valve with no aortic stenosis or insufficiency.Postoperatively, the patient was transferred to the cticu and was discharged home in stable condition on pod# 3.Pathology report: the explanted bioprosthetic valve shows leaflet calcification and annular pannus overgrowth.

• 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; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16048754
• MDR Text Key: 306159336
• Report Number: 2015691-2022-10371
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194968
• UDI-Public: (01)00690103194968(17)190922
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2019
• Device Model Number: ASKU
• 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: 03/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2017
• 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: 64 YR
• Patient Sex: Male