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

Model Number 8300AB23A

Device Problems Calcified (1077); Insufficient Information (3190)

Patient Problems Anemia (1706); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 03/06/2024

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

It was learned via the patient registry that a patient with a 23mm 8300ab intuity valve underwent a redo aortic valve replacement procedure after an implant duration of six (6) years, six (6) months due to unknown reasons.The explanted valve was replaced with a 23mm 11500a inspiris valve.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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.A capa/scar/pra is not required, as there are no confirmed product or labeling non-conformances and no other triggers are met.The most likely cause is patient factors, including hyperlipidemia and chronic kidney disease.

Event Description

It was learned via the patient registry that a patient with a 23mm 8300ab intuity valve underwent a redo aortic valve replacement procedure after an implant duration of six (6) years, six (6) months due to severe aortic valve insufficiency secondary to calcification.The patient presented with acute-on-chronic congestive heart failure and anemia.The explanted valve was replaced with a 23mm 11500a inspiris valve.The valve seated well.The aortic valve was functioning well and hemodynamics were acceptable but marginal.Iabp was inserted to support post cardiotomy myocardial dysfunciton.The patient was transferred to the cvicu in critical but stable condition.Post-operative course was further complicated by atrial fibrillation/flutter treated with amiodarone and then prolonged qtc on oral beta-blockers.The patient was discharged home on pod #10.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• 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: 19054917
• MDR Text Key: 339549527
• Report Number: 2015691-2024-02636
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194494
• UDI-Public: (01)00690103194494(17)181023
• 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: Other,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2024

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 Expiration Date: 10/23/2018
• Device Model Number: 8300AB23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/09/2024
• Date Device Manufactured: 10/23/2016
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male