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

Model Number 8300AB

Device Problems Leak/Splash (1354); Perivalvular Leak (1457)

Patient Problems Aortic Valve Stenosis (1717); Hemorrhage/Bleeding (1888)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

Udi # (b)(4).The device was not returned to edwards for evaluation.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; however, it is likely that patient related factors contributed to the event.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported that a 25mm aortic valve, implanted approximately for one (1) month, was explanted due to severe aortic insufficiency and large paravalvular leak.The explanted device was replaced with a 25mm 3300tfx bioprosthetic valve.Post procedure, the patient had no paravalvular leaks or evidence of any significant problems.The patient was transferred to the icu with stable hemodynamics.The patient was discharged on pod #6 in stable condition.Per medical records, the patient presented with severe regurgitation and paravalvular leak.Intraoperative, there was a large area about 1/3 of the valve circumference for which there was no evidence of healing.This was the paravalvular leak.The valve was grasped and put under some tension with the intent of scraping it out of the outflow tract with a clamp.At this point, the valve just fell out.There was very little healing and very little tissue anchoring in this prosthesis.The annulus was debrided and a 25mm 3300tfx valve was implanted.The patient was transferred to the icu with stable hemodynamics.The patient was discharged on pod #6 in stable condition.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• 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: 9241830
• MDR Text Key: 166759176
• Report Number: 2015691-2019-03978
• 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: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2023
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR