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

Model Number 11500A23

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

Patient Problems Pulmonary Edema (2020); Heart Failure/Congestive Heart Failure (4446)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: bioprosthetic tissue valves can deteriorate with time and eventually fail contributing to regurgitation and/or stenosis.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants/replacements and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.In this case, calcification was indicated.Calcification plays a major role in the failure of bioprosthetic heart valves.Calcification of valves occurs as a progressive, time-dependent process.Tissue valve calcification is initiated primarily within residual cells that have been devitalized.Initial calcification deposits eventually enlarge and grow into a mass, which stiffen and weaken the tissue and thereby cause the prosthesis to malfunction.The mineralization of a biomaterial is generally enhanced at the sites of intense mechanical deformations generated by motion, such as the points of flexion in heart valves.Ultimately, the result of calcification is valve failure due to tearing or stenosis.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 bioprosthesis from calcifying.The root cause of this event cannot be determined with the available information.However, this event was most likely impacted by the progression of the patient's underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.The device was returned and evaluated.See evaluation summary below.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.Evaluation summary: customer reports of calcification, degeneration, leaflet thickening, reduced leaflet mobility, and stenosis 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.Extrinsic calcific deposits were observed on the outflow surfaces of all three leaflets.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 7mm on leaflet 3 at the inflow aspect.Host tissue overgrowth on the stent circumference was moderate at both the inflow and outflow aspects.Calcification and host tissue overgrowth restricted leaflet mobility and led to stenosis.Sewing ring was cut off from the valve and exposed the metal band on the inflow aspect.Cut off sewing ring fragment was not returned.Wireform was also exposed on commissure 3.

Event Description

Edwards received notification that an inspiris resilia valve model 11500a23 implanted in the aortic position was explanted after an implant duration of 1 year and 6 months due to heavy calcification, degeneration and leaflet thickening in all leaflets, leading to stenosis and reduced leaflet mobility in all leaflets.As reported, the prosthesis itself was heavily calcified, with several calcification within the leaflets.The patient presented with syncope and acute heart failure, dyspnea nyha class iv and pulmonary edema before the procedure.A valve model 2800tfx23mm was successfully implanted in replacement.The patient's outcome was noted as hospitalized in stable condition.

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.Calcification is most commonly related to patient factors and is not usually an indication of a device malfunction.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.The root cause of this event cannot be determined with the available information.However, this event was most likely impacted by the progression of the patient's underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.

Event Description

Edwards received notification that an inspiris resilia valve model 11500a23 implanted in the aortic position was explanted after an implant duration of 1 year and 6 months due to heavy calcification, degeneration and leaflet thickening in all leaflets, leading to stenosis and reduced leaflet mobility in all leaflets.As reported, the prosthesis itself was heavily calcified, with several calcification within the leaflets.The patient presented with syncope and acute heart failure, dyspnea nyha class iv and pulmonary edema before the procedure.A valve model 2800tfx23mm was successfully implanted in replacement.The patient's outcome was noted as hospitalized in stable condition.As per product evaluation, customer reports of calcification, degeneration, leaflet thickening, reduced leaflet mobility, and stenosis 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.Extrinsic calcific deposits were observed on the outflow surfaces of all three leaflets.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 7mm on leaflet 3 at the inflow aspect.Host tissue overgrowth on the stent circumference was moderate at both the inflow and outflow aspects.Calcification and host tissue overgrowth restricted leaflet mobility and led to stenosis.

• 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: gail warner ; 1 edwards way; irvine, CA 92614 ; 9492504096
• MDR Report Key: 12546643
• MDR Text Key: 273775672
• Report Number: 2015691-2021-05406
• 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,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

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: 11500A23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 11/30/2021
• Supplement Dates FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male