MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE AORTIC VALVE; TISSUE HEART VALVE

Model Number 8300AB

Device Problems Fluid/Blood Leak (1250); Perivalvular Leak (1457)

Patient Problem Aortic Regurgitation (1716)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: udi (b)(4).The device was not returned to edwards for evaluation.Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.While the majority of affected patients are asymptomatic, it can lead to significant morbidity including heart failure and hemolytic anemia.Pvl can occur in the mitral and aortic position for similar reasons, including technique and patient related factors.The type and cause of regurgitation varies depending upon multiple factors.Typically, mild regurgitation is not unusual after initial valve replacement, and is usually tolerated by patients.Often moderate to high regurgitation requiring re-operation in the immediate post-operation period is due to procedural related issues and is unrelated to the device.Regurgitation which develops progressively over time can be due to number of issues including patient related factors or structural valve deterioration.A definitive root cause could not be determined.If additional information is received a supplemental mdr will be submitted.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported that a patient with a 25mm valve implanted for two years, one month was explanted due to perivalvular leak.A 25mm valve was implanted in replacement.Postop transesophageal echo revealed normally functioning aortic valve with no perivalvular leak preserved right and left ventricular function.The patient returned to the cardiac icu.The patient was discharged home on pod #4.

Manufacturer Narrative

The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Aortic regurgitation in bioprosthetic heart valves, also known as aortic insufficiency, occurs when the valve does not close properly in diastolic phase, which results in retrograde flow of blood into the left ventricle.The type and cause of regurgitation varies depending upon multiple factors.Regurgitation which develops progressively over time can be due to a number of issues including patient related factors or structural valve deterioration.However, advances in valve design and bioprosthetic material have been made with the intention of reducing leaks by providing more efficient hemodynamics and longer tissue durability.A definitive root cause could not be determined.If additional information is received a supplemental mdr will be submitted.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

• Brand Name: EDWARDS INTUITY ELITE AORTIC VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11124243
• MDR Text Key: 225313092
• Report Number: 2015691-2021-00024
• 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,other
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 96