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

Model Number 8300AB23

Device Problem Perivalvular Leak (1457)

Patient Problem Aortic Regurgitation (1716)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).Paravalvular leak (pvl) refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue.It may occur as a result of a lack of appropriate sealing of the valve at the annulus.The most common reason for pvl is inadequate debridement of a calcified annulus and is not a result of device malfunction.There may be small pvls identified intra-operatively or post-operatively which do not require any intervention.Most cases of pvl noted intra-operatively are corrected with standard surgical techniques during the initial implant procedure and do not lead to serious injury or death.Technique-related factors, such as incorrect valve sizing, have been shown to contribute to the development of pvl.Under sizing can lead to a gap between the annulus and sewing ring since the valve implanted is too small in relation to the annulus.The use of pledgeted sutures during aortic valve replacement was thought to decrease the incidence of pvl.However, recent studies have concluded that non-pledgeted suture techniques offer an equivalent alternative to the traditional use of pledgets during aortic valve replacement, with no increase in pvl rates.Anatomical factors may create difficulty seating the bioprosthetic valve resulting in pvl.The anatomy of the annulus may induce mechanical stresses along the rigid bioprosthetic ring which can influence long-term valve performance and durability.The annulus is not a static structure and has dynamic characteristics which have been shown to play a critical role in valve function and efficiency.A diseased or rigid annulus can potentially increase the mechanical stress on the prosthetic valve, leading to pvl.Edwards conducts manufacturing and inspection tests to ensure optimum functionality of each valve prior to final distribution.Such tests used to evaluate if edwards' valves meet specification include forward flow testing to determine the pressure gradient across the open valve and a coaptation test under constant hydrostatic back pressure to visually evaluate the coaptation of the leaflets.The subject device is not available for evaluation as it remains implanted in the patient.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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 reported that a patient with a 23mm 8300ab pericardial aortic valve exhibited severe pvl after an implant duration of approximately 11 months.The patient was admitted to the hospital with heart failure.At an implant duration of one (1) year the patient underwent balloon aortic valvuloplasty resulting in a decrease from severe to mild pvl.Bav was performed once more with minimal change.A 7mm amplatzer vascular plug was deployed.Pvl decreased slightly.The patient was noted to be doing well with major improvements by echo.That patient remains in the hospital for non-cardiac reasons.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: amritha srinivasan ; 1 edwards way; mle-2; irvine, CA 92614 ; 9492504062
• MDR Report Key: 10992187
• MDR Text Key: 220939476
• Report Number: 2015691-2020-14964
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2020

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: 02/02/2022
• Device Model Number: 8300AB23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/11/2020
• Date Device Manufactured: 02/03/2018
• 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 Age: 64