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

Model Number 8300AB

Device Problems Degraded (1153); Gradient Increase (1270); Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 03/13/2021

Event Type  Injury  

Manufacturer Narrative

Stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient-related contributing factors.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants 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, may contribute to stenosis and/or regurgitation.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.The root cause of this event cannot be conclusively determined with the available information.However, the progression of the patient's underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction may have contributed to this event.The subject device is not available for evaluation, as it remains implanted in the patient.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.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, an appropriate investigation will be performed.

Event Description

It was reported that a patient with a 23mm 8300ab aortic valve, implanted for three (3) years, four (4) months, is experiencing high gradients.No other details have been provided.Internal review of echo images: tee reveals some degree of leaflet thickening and gradients suggesting severe aortic stenosis.In general high trans-aortic peak velocity and gradients could be due to lvot obstruction, prosthesis-patient mismatch, non-obstructive phenomena such as high flow or pressure recovery, or a combination of factors.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections: b5, g3, g6, h2, h6 (device codes), and h10: h10: bioprosthetic tissue valves can deteriorate with time and eventually fail contributing to regurgitation and/or endo.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants 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.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular regurgitation and/or stenosis.The subject device is not available for evaluation, as it remains implanted in the patient.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 root cause of this event cannot be conclusively determined with the available information.However, the progression of the patient's underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction may have contributed to this event.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, an appropriate investigation will be performed.

Event Description

Edwards learned of a planned intervention on a 23mm 8300ab aortic valve, implanted for three (3) years, four (4) months, due to high gradients.Internal review of echo images revealed some degree of leaflet thickening with reduced systolic opening and gradients suggesting severe aortic stenosis.

Manufacturer Narrative

H11: corrective data: corrected section: h6 (type of investigation and investigation findings).

• Brand Name: EDWARDS INTUITY ELITE AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11630939
• MDR Text Key: 251869503
• Report Number: 2015691-2021-02318
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194494
• UDI-Public: 00690103194494
• Combination Product (y/n): N
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2021

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 Operator: Health Professional
• Device Expiration Date: 08/07/2021
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2021
• Initial Date FDA Received: 04/07/2021
• Supplement Dates Manufacturer Received: 04/28/2021; 05/10/2021
• Supplement Dates FDA Received: 04/29/2021; 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR