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

Model Number 8300AB

Device Problems Calcified (1077); Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270); Difficult to Open or Close (2921)

Patient Problem Dyspnea (1816)

Event Date 11/22/2022

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 patient with an elite 8300ab19 valve implanted in the aortic position underwent a valve-in-valve procedure after an implant duration of approximately five (5) years and eight (8) months due to degeneration caused by annulus calcification leading to high gradient and mild insufficiency.The patient presented with dyspnea.A 20mm transcatheter valve was successfully implanted within the pre-existing surgical device using the transfemoral approach.The patient was noted as to be in well condition and discharged at home.

Event Description

Edwards received notification that a patient with an elite 8300ab19 valve implanted in the aortic position underwent a valve-in-valve procedure after an implant duration of approx.Five (5) years and eight (8) months due to degeneration with severe leaflet thickening caused by annulus calcification leading to mild insufficiency and high gradient (peak/mean gradient: 80/49 mmhg).The patient presented with dyspnea.A 20mm sapien3 valve was successfully implanted within the pre-existing surgical device using the transfemoral approach.The patient was noted as to be in well condition and discharged at home.

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.

Manufacturer Narrative

H10: additional manufacturer narrative: the serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.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.The most likely cause is patient factors, including diabetes.

Event Description

Edwards received notification that a patient with an elite 8300ab19 valve implanted in the aortic position underwent a valve-in-valve procedure after an implant duration of approximately five (5) years and eight (8) months due to degeneration caused by annulus calcification leading to mild insufficiency and high gradient (peak/mean gradient: 80/49 mmhg).There was severe leaflet thickening due to calcification, with the non-coronary leaflet being motionless.The patient presented with dyspnea.A 20mm transcatheter valve was successfully implanted within the pre-existing surgical device using the transfemoral approach.The patient was noted as to be in well condition and discharged at home.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• 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 m201; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16003152
• MDR Text Key: 305679914
• Report Number: 2015691-2022-10097
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150036
• 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,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Hospitalization; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Female