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

Model Number 8300AB

Device Problem Perivalvular Leak (1457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2020

Event Type  Injury  

Manufacturer Narrative

The device was returned to edwards for evaluation.Evaluation is in progress.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.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 manufacturing issue was not identified.A definitive root cause could not be determined; however, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards received information that a 21mm aortic valve, implanted approximately one (1) year, was explanted due to paravalvular leak.The device was originally implanted for aortic valve replacement to correct aortic stenosis.After implant, mild paravalvular leak was detected.The patient had been monitored, but the condition has not been improved.The device was explanted and replaced with a 23mm aortic valve with no adverse patient events reported.Upon the valve explant, paravalvular leak from the area between corresponds to the right-coronary cusp and the non-coronary cusp was detected.The surgeon commented that the encroachment of host tissue on that area was insufficient and thin.The patient status was reported as ¿under treatment.¿ there was no allegation of device malfunction.

Manufacturer Narrative

H3.Device evaluation: customer report of paravalvular leak could not be confirmed through visual observations.Report of host tissue overgrowth was confirmed.As received, x-ray demonstrated valve frame was expanded and was pushed inward at commissures (b)(4) and (b)(4).Host tissue on the stent circumference was moderate on both the outflow and inflow aspects.A green suture thread remained at the black stitch marking around leaflet 2 and the suture holes were not visible near the other two black stitch markings on the sewing ring due to host tissue overgrowth.H10.Additional manufacturer narrative: updated sections h3 and h6.

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: 9903631
• MDR Text Key: 188405268
• Report Number: 2015691-2020-11238
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2021
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention