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

Model Number 11500A

Device Problems Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2023

Event Type  Injury  

Manufacturer Narrative

H10 additional 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 38-year-old patient with a valve model 11500a25 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 degeneration leading to moderate to severe regurgitation and increased gradients.As reported, the patient already presented signs of degeneration with increased gradients (mean gradient 58mmhg) 4 months before re-intervention.As reported, the patient was asymptomatic.Last toe suggested moderate to severe aortic transvalvular regurgitation, normal leaflet movement, no stenosis.A 29mm transcatheter valve was successfully implanted within the surgical device.The patient was noted as to be discharged home on post-operative day 2.

Manufacturer Narrative

Added information to section h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).H10: additional manufacturer narrative: the device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.The device was not returned for evaluation as it remained implanted after the valve-in-valve (viv) procedure.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.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.

Event Description

Edwards received notification that a 38-year-old patient with a valve model 11500a25 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 degeneration leading to moderate to severe regurgitation and increased gradients.As reported, the patient already presented signs of degeneration with increased gradients (mean gradient 58mmhg) 4 months before re-intervention.As reported, the patient was asymptomatic.Last toe suggested moderate to severe aortic transvalvular regurgitation, normal leaflet movement, no stenosis.Reportedly, this young patient was fit and a heavy weight lifter.Surgeons theorized that the heavy weight lifting and the excessive exercise could have had affected the changing pressures within the heart and the valve functionality.A 29mm transcatheter valve was successfully implanted within the surgical device.The patient was noted as to be discharged home on post-operative day 2.

• 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: 18384295
• MDR Text Key: 331288803
• Report Number: 2015691-2023-18734
• 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
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2021
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2019
• 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; Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 108 KG