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

Model Number 11500A

Device Problems Calcified (1077); Thickening of Material (4056)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 10/27/2023

Event Type  Injury  

Manufacturer Narrative

The subject device is not available for evaluation as it remains implanted in the patient.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 a 11500a23 valve model implanted in the aortic position underwent a valve-in-valve procedure after an implant duration of three (3) years and four (4) months due to valve leaflet/cusp thickening leading to moderate reduced mobility and aortic valve stenosis.The patient presented a mean gradient of 45 mmhg, a max gradient of 80 mmhg and an effective orifice area of 0.9 cm2.As, reported patient presented with nyha ii.A 26mm transcatheter valve was successfully implanted within the pre-existing surgical device.

Manufacturer Narrative

H10: additional manufacturer narrative: 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.The subject device was not returned for evaluation as it remains implanted within the patient.Additionally, no medical records or operative report were provided for evaluation.Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.Structural valve deterioration (svd) can, and typically does, lead to chronic central leaks over a period of time.Svd is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Degeneration-related structural deterioration is most commonly related to patient factors and is not usually an indication of a device malfunction related to a manufacturing deficiency.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.The most likely cause is patient factors, including atrial fibrillation and diabetes type ll.

Event Description

Edwards received notification that this 63-year-old patient with a 11500a23 valve model implanted in the aortic position underwent reintervention for a valve-in-valve procedure after an implant duration of three (3) years and four (4) months due to calcific degeneration and leaflet restricted motion leading to severe stenosis (opening area of 0,8 cm2, velocity 4,33 m/sec and mean gradient 47mmhg) and mild insufficiency.As reported, patient presented with shortness of breath (nyha class ii).A 26mm sapien 3 ultra transcatheter valve was implanted within the surgical edwards valve using the transfemoral approach with good results: no evidence of paravalvular leak nor insufficiency.Patient was discharged home in good conditions.

Manufacturer Narrative

Updated information to section b5, b6, b7 and h6 (device code(s)).Corrected data h6 (device code(s)): "4056 - thickening of material" code removed.H11: additional 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 related to a manufacturing deficiency.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.The most likely cause is patient factors, including atrial fibrillation, diabetes type ll and coronary artery 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 ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18833600
• MDR Text Key: 336852859
• Report Number: 2015691-2024-01574
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194982
• UDI-Public: (01)00690103194982(17)211030(11)191031
• 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,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2024

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 Expiration Date: 10/30/2021
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 03/25/2024; Not provided
• Supplement Dates FDA Received: 03/27/2024; 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 107 KG