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

Model Number 8300AB21

Device Problems Calcified (1077); Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270); Difficult to Open or Close (2921); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Fatigue (1849); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 11/01/2023

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.

Event Description

Through implant patient registry it was learned that a 21mm 8300ab valve in the aortic position, was explanted after an implant duration of 5 years, 9 months due to unknown reason.The explanted valve was replaced with a 23mm 11500a valve.

Event Description

Through implant patient registry it was learned that a 21mm 8300ab valve in the aortic position, was explanted after an implant duration of five (5) years, nine (9) months due to calcification, severe stenosis, regurgitation, thickening, and restricted motion.The explanted valve was replaced with a 23mm 11500a valve.Per medical records, the patient presented with dyspnea on exertion and fatigue.The patient underwent redo avr was performed with 23mm 11500a valve.Intraoperatively, valve leaflets to be calcified and stenotic.Post-bypass tee demonstrated prosthetic valve to be well-seated, no paravalvular leak.Pathology report identified aortic valve with three cusps slightly firm and calcified.The patient was transferred to icu in stable condition.

Manufacturer Narrative

Added information to b5, b7, h6.

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 valves 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 regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.The most likely cause is patient factors, including coronary artery disease, dyslipidemia and diabetes mellitus.

Manufacturer Narrative

H3: evaluation summary: customer report of calcification and thickening were confirmed through observed calcification on remaining leaflets.Report of regurgitation, stenosis and restricted motion was unable to be confirmed in the as received condition.X-ray demonstrated heavy calcification on the remainder of all three leaflets.Calcification was observed on host tissue on the sewing ring near commissure 1.X-ray demonstrated frame was expanded, deformed, and pushed inward around commissure 1.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 2mm on leaflet 2 at the outflow aspect.Host tissue was heavy at the frame inflow aspect and moderate at the stent outflow aspect.As received, all three leaflets had cuts of approximately 3mm x 9mm on leaflet 1, 5mm x 8mm on leaflet 2, and 2mm x 15mm on leaflet 3.The cuts had a smooth and straight edge; cut leaflet were not returned.Leaflet 1 had a 3mm tear near commissure 1, leaflet 2 had a 5mm tear near commissure 2, leaflet 3 had a 6mm tear at the cusp.Calcification was evident at the tears.The sewing ring was partially cut around the valve and exposed the wireform on the inflow aspect.Cut sewing ring fragment remained attached to the valve.Wireform was also exposed around all three commissures.One green suture thread and suture fastener remained attached to the sewing ring.Suture hole was visible near one of the three black stitch markings on the sewing ring; one suture hole near each.

Event Description

Through implant patient registry it was learned that a 21mm 8300ab valve in the aortic position, was explanted after an implant duration of five (5) years, nine (9) months due to calcification, severe stenosis, regurgitation, thickening, and restricted motion.The explanted valve was replaced with a 23mm 11500a valve.Per medical records, the patient presented with dyspnea on exertion and fatigue.The patient underwent redo avr with a 23mm 11500a valve.Intraoperatively, valve leaflets were calcified and stenotic.Post-bypass tee demonstrated prosthetic valve to be well-seated, no paravalvular leak.Pathology report identified aortic valve with three cusps slightly firm and calcified.The patient was transferred to icu in stable condition.Per product evaluation, x-ray demonstrated heavy calcification on the remainder of all three leaflets.Calcification was observed on host tissue on the sewing ring near commissure 1.Calcification was evident at the leaflet tears.

• 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: 18248087
• MDR Text Key: 329500618
• Report Number: 2015691-2023-17847
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194487
• UDI-Public: (01)00690103194487(17)181005
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/15/2024

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 Operator: Health Professional
• Device Expiration Date: 10/05/2018
• Device Model Number: 8300AB21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 12/06/2023; Not provided; 01/31/2024
• Supplement Dates FDA Received: 12/28/2023; 01/08/2024; 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2016
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female