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

Model Number 11500A

Device Problems Calcified (1077); Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270); Difficult to Open or Close (2921); Patient Device Interaction Problem (4001)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 10/31/2022

Event Type  Injury  

Event Description

Edwards received notification that an inspiris resilia valve model 11500a25 implanted in the aortic position was explanted after an implant duration of two (2) years and five (5) months due to calcific degeneration causing reduced motions of the three leaflets, severe stenosis (mean gradient of 84mmhg) and moderate aortic regurgitation.The patient presented in icu in nhya class iii, chest pain and dyspnea at minimal exertion for the last fifteen days.Tte showed a preserved lvef (55-60%) and a slightly dilated lv.No vegetation.No evidence of thrombosis.Good right ventricular function.Soon after admission for valve replacement, a cardiac arrest due to cardiogenic acute pulmonary edema occurred and the patient was put on ecmo.Due to persistence of ventricular fibrillation despite external electrical shocks and in front of this major cardiogenic shock it was decided to proceed urgently to valve replacement.A mechanical valve was implanted in replacement.The patient died on pod # 2.As reported, there was no allegation of device malfunction and it was considered that the illness (renal disfunction, dialysis and atheromatous disease were the cause of the early svd.).

Manufacturer Narrative

Additional 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

Edwards received notification that an inspiris resilia valve model 11500a25 implanted in the aortic position was explanted after an implant duration of two (2) years and five (5) months due to calcific degeneration causing reduced motions of the three leaflets, severe stenosis (mean gradient of 84mmhg) and moderate aortic regurgitation.Per product evaluation findings, moderate host tissue overgrowth was also observed.The patient presented in icu in nhya class iii, chest pain and dyspnea at minimal exertion for the last fifteen days.Tte showed a preserved lvef (55-60%) and a slightly dilated lv.No vegetation.No evidence of thrombosis.Good right ventricular function.Soon after admission for valve replacement, a cardiac arrest due to cardiogenic acute pulmonary edema occurred and the patient was put on ecmo.Due to persistence of ventricular fibrillation despite external electrical shocks and in front of this major cardiogenic shock it was decided to proceed urgently to valve replacement.A mechanical valve was implanted in replacement.The patient died on pod # 2.As reported, there was no allegation of device malfunction and it was considered that the illness (renal disfunction, dialysis, and atheromatous disease) were the cause of the early svd.

Manufacturer Narrative

The device was returned for evaluation.Customer reports of calcific degeneration, reduced leaflet motion, and stenosis were confirmed.Report of regurgitation could not be confirmed through visual observations.The x ray demonstrated the metal band was deformed outward around commissure 3, the vfit cocr alloy band was not expanded.X-ray also demonstrated heavy calcification on all three leaflets.Extrinsic calcific deposits were observed on the outflow surfaces of all three leaflets and inflow surfaces of leaflet 1.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 6mm on leaflet1 at the inflow aspect.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 4mm on leaflet 1 at the outflow aspect.Host tissue overgrowth fused leaflets 1 and 2 by approximately 4mm at commissure 2 on the outflow 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 off and exposed the metal band around the valve on the inflow aspect.Wireform was also exposed on commissure 2.Engineering evaluation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.

Manufacturer Narrative

H10: additional manufacturer narrative: added information to section d4 (expiration date) and h4 (device manufacturer date).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.

Manufacturer Narrative

H10 manufacturer narrative: updated: h6 (device code(s), type of investigation, investigation findings, investigation conclusions).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.Calcification is most commonly related to patient factors and is not usually an indication of a device malfunction.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.Host fibrous (pannus) tissue growth is not a malfunction of the device.The most likely cause is patient factors, including renal disfunction, dialysis and atheromatous disease.

• 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: 16001472
• MDR Text Key: 305683231
• Report Number: 2015691-2022-10091
• 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,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2021
• 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: 02/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2019
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 80 KG