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

Model Number 11500A

Device Problems Calcified (1077); Gradient Increase (1270); Difficult to Open or Close (2921)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 12/19/2022

Event Type  Injury  

Event Description

It was reported that a patient with a 11500a 23mm aortic valve underwent a redo-avr procedure after an implant duration of two (2) years, 10 months, due to calcification and stenosis.Patient presented with heart failure.A non-edwards mechanical valve was implanted in replacement.Patient outcome good.

Manufacturer Narrative

The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information is in process.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 events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

Device evaluation: customer reports of calcification, restricted leaflet mobility, and stenosis were confirmed.Report of elevated gradient was unable to be confirmed through visual observation.As received, all three leaflets were stiff and translucent like due to dehydration.The xray demonstrated the wireform and cocr band remained intact, the vfit cocr allow band was not expanded.Xray also demonstrated heavy calcification on all three leaflets.Extrinsic calcific deposits were observed on the surfaced of all three leaflets on both the inflow and outflow aspects.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 2mm on leaflet 1 at the inflow aspect.Host tissue overgrowth on the stent circumference was minimal at the outflow aspect.Calcification and host tissue overgrowth restricted leaflet mobility and led to stenosis.Wireform was exposed on commissure 3.Corrected b5, b7.

Event Description

It was reported that a patient with a 11500a 23mm aortic valve was explanted after an implant duration of two (2) years, 10 months, due to severely calcified prosthetic valve leaflets with restricted mobility, severe stenosis, and elevated gradients.A non-edwards mechanical valve was implanted in replacement.Per medical records, the patient presented symptomatic with shortness of breath.She underwent a redo avr, intraoperative findings: severely calcified prosthetic valve leaflets.A non-edwards 23mm on-x mechanical valve was implanted in replacement.Patient tolerated the procedure well and was discharged home on pod #17.Hospital pathology report: minimal pannus formation is noted on the inflow and outflow surfaces.The cusps demonstrate severely restricted mobility.Severe calcification is identified.One cusp demonstrates a tear.No vegetations or thrombi were found.

Manufacturer Narrative

The device history record 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.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 valves 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 most likely cause is patient factors, including chronic renal failure stage iii, diabetes mellitus, and hyperlipidemia.

Event Description

It was reported that a patient with a 11500a 23mm aortic valve underwent a redo-avr procedure after an implant duration of two (2) years, 10 months, due to calcification, severe stenosis, and elevated gradients.Patient presented with heart failure, shortness of breath, lethargy, and reduced effort tolerance.A non-edwards mechanical valve was implanted in replacement.Patient outcome good.

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 valves 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 most likely cause is patient factors, including chronic renal failure stage iii, diabetes mellitus, radiation therapy and hyperlipidemia.

• 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; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16157997
• MDR Text Key: 307289135
• Report Number: 2015691-2023-10153
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194982
• UDI-Public: (01)00690103194982(17)241022
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/29/2023

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 Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 01/13/2023; 02/15/2023; 03/03/2023; 04/26/2023
• Supplement Dates FDA Received: 02/07/2023; 02/17/2023; 03/28/2023; 04/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2019
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female