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

Model Number 8300AB

Device Problems Calcified (1077); Degraded (1153); Gradient Increase (1270); Difficult to Open or Close (2921); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: multiple requests for additional information have been performed; however, no response at this time.The explanted valve has been returned for evaluation; however, the analysis is still in progress.A supplemental report will be submitted accordingly once the product evaluation has been completed.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 this(b)(6) year old female patient with an elite valve model 8300ab21 implanted in the aortic position was explanted after an implant duration of 7 years.The reason was not provided.As reported, the patient had oncological treatment and radiations could have potentially caused or contributed to the valve damage.

Manufacturer Narrative

Bioprosthetic tissue valves can deteriorate with time and eventually fail contributing to regurgitation and/or stenosis.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants/replacements 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.In this case, calcification was indicated.Calcification plays a major role in the failure of bioprosthetic heart valves.Calcification of valves occurs as a progressive, time-dependent process.Tissue valve calcification is initiated primarily within residual cells that have been devitalized.Initial calcification deposits eventually enlarge and grow into a mass, which stiffen and weaken the tissue and thereby cause the prosthesis to malfunction.The mineralization of a biomaterial is generally enhanced at the sites of intense mechanical deformations generated by motion, such as the points of flexion in heart valves.Ultimately, the result of calcification is valve failure due to tearing or stenosis.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 bioprosthesis from calcifying.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 was most likely due to patient related factors and the progression of the underlying valvular disease pathology contributed to the event.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections: b5, and h6 (device code(s)).

Event Description

Edwards received notification that this 53-y-o female patient with an elite valve model 8300ab23 implanted in the aortic position was explanted after an implant duration of 7 years for unknown reasons.After product evaluation, the valve was found presented with calcification, pannus, thickened and swollen leaflets leading to restricted leaflet mobility and stenosis.As reported, the patient had oncological treatment, and radiations could have potentially caused or contributed to the valve damage.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: gail warner ; 1 edwards way; mailstop ant 6.1; irvine, CA 92614 ; 9492504096
• MDR Report Key: 12601763
• MDR Text Key: 277630229
• Report Number: 2015691-2021-05583
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2021

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: 08/04/2016
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/08/2021
• Supplement Dates Manufacturer Received: 10/14/2021; 12/07/2021
• Supplement Dates FDA Received: 11/08/2021; 12/07/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/05/2014
• 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: 53 YR
• Patient Sex: Female