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

Model Number 11500AJ21

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

Patient Problems Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

H10: 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 information that the gradient pressure increase was seen to a patient with a 21mm 11500 pericardial aortic valve which was implanted for one (1) year four (4) months and it remained implanted.One of the leaflets which corresponds to the left-coronary cusp was not moving through the echo image.

Manufacturer Narrative

Leaflet immobility or leaflet restriction occurring over time, and not due to extrinsic physical interference, is a form of structural valve deterioration, which can result in significant regurgitation and/or stenosis.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.An engineering evaluation is not required because there is no allegation of a malfunction which could be related to a manufacturing non-conformance; no labeling non-conformance/deficiency; no use-related issue with a hazardous situation; no device-related infection; and there is no evidence of a product failure with regard to design, reliability, or use error.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.A capa/scar/pra is not required as there are no confirmed product or labeling nonconformances and no other triggers are met.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.

Event Description

Edwards received information that the gradient pressure increase was seen to a patient with a 21mm 11500 pericardial aortic valve which was implanted for one (1) year four (4) months and it remained implanted.One of the leaflets which corresponds to the left-coronary cusp was not moving through the echo image.A symptom of heart failure is seen when walking on a slope, however, it is milder than before the device was implanted to the patient.Surgical treatment is under consideration next year, however, no medial or surgical treatment has been given to the patient at the moment.The device will not be returned for evaluation as it remained implanted.Moving image of the echo was provided by the customer for evaluation.Echo image itself was not provided by the customer.The customer commented that the gradient pressure increase was not seen right after the implant surgery, but the pressure increased later on.Leaflet did not appear to be hardened by calcification.

• 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; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18031113
• MDR Text Key: 326867096
• Report Number: 2015691-2023-17148
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 11500AJ21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR