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

Model Number 8300AB19

Device Problem Perivalvular Leak (1457)

Patient Problem Aortic Regurgitation (1716)

Event Date 09/08/2020

Event Type  Injury  

Manufacturer Narrative

Stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient related contributing factors.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants 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, may contribute to stenosis and/or regurgitation.Alternatively, the nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.The root cause of this event cannot be conclusively determined with the available information.However, the stenosis in this case was most likely impacted by the progression of the patient¿s underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.The subject device is not available for evaluation as it was discarded at the site.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.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 elite valve model 8300ab19 was explanted after an implant duration of 1 (one) day due to paravalvular leak grade +3.A valve model 3300tfx19mm seemed to better fit with patient's small annulus and was implanted in replacement.The patient was noted as to be recovered after the procedure.The surgeon stated the issue was not related to a product failure but due to procedural technique.The explanted device was not returned for evaluation as it was discarded.Indication for initial replacement was aortic valve stenosis.Cabg x 2 was performed concomitantly.

Manufacturer Narrative

Updated: b4, g4, h6.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10949883
• MDR Text Key: 219937474
• Report Number: 2015691-2020-14839
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2023
• Device Model Number: 8300AB19
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 70