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

Model Number 8300AB

Device Problems Calcified (1077); Difficult to Open or Close (2921); Patient Device Interaction Problem (4001)

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

Event Date 07/01/2021

Event Type  Injury  

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) was not reviewed as the device serial number was not provided.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 an elite valve model 8300ab was explanted from the aortic position after an implant duration of approx.2 years and 5 months due to calcification.No other information was provided at the time of the reported event.The implant date is known only as "2018".Therefore, (b)(6) 2018 is being used to calculate the minimum implant duration.

Manufacturer Narrative

Evaluation summary: customer report of calcification was confirmed.X-ray demonstrated heavy calcification on leaflet 1 and 3, and minimal calcification on leaflet 2.Calcification restricted leaflet mobility and led to stenosis.X-ray demonstrated frame was expanded, deformed and pushed inward around all three commissures.Host tissue was moderate at the frame inflow and outflow aspects.Host tissue fused leaflets 1 and 2 by approximately 4 mm at commissure 2 on the outflow aspect.Leaflet 2 and leaflet 3 had a 1 mm tear near commissure 3.Calcification was evident at the tears.Suture hole was visible near one of the three black stitch markings on the sewing ring.

Event Description

Edwards received notification that an elite valve model 8300ab25 was explanted from the aortic position after an implant duration of 3 years and 4 months due to bioprosthesis calcification leading to restricted motion of the leaflets.The patient presented with short of breath and dizziness.A 3300tfx25mm valve was implanted in replacement.The device was returned for evaluation.Valve calcification was confirmed.Moderate host tissue overgrowth at the frame inflow and outflow aspects was also observed.

Manufacturer Narrative

H10: additional manufacturer narrative: corrected: d4 (serial number).Updated: b4, d4 (expiration date), g3, g6, h2, h4, h6.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.

• 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
• MDR Report Key: 12214248
• MDR Text Key: 263434198
• Report Number: 2015691-2021-04297
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/10/2021
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention