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

Model Number 8300AB

Device Problem Perivalvular Leak (1457)

Patient Problem Failure of Implant (1924)

Event Date 05/05/2019

Event Type  Injury  

Manufacturer Narrative

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; 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 learned that a 27mm valve was explanted due to paravalvular leak (pvl) 8 days after the implant.As reported, paravalvular leak was observed 6 days after the implantation.The implantation of the valve went well.The surgeon placed 3 sutures in the ncc and 1 each in other 2 cusps (5 total) and patient was doing well post op.The valve was explanted 2 days after detection of the pvl and replaced with a 29mm valve.

Event Description

Edwards learnt that a 27mm valve was explanted due to paravalvular (pvl) 8 days after the implant.As reported, moderate to severe paravalvular leak was observed 6 days after the implantation.Patient had a very large bicuspid valve, the sizing for a 27mm valve appeared to be sufficient, but the valve turned out to be not quite large enough for the patients anatomy.The implantation of the valve went well.The surgeon placed 3 sutures in the ncc and 1 each in other 2 cusps (5 total) and patient was doing well post op.The valve was explanted 2 days after detection of the pvl and replaced with a 29mm valve.Patient outcome post redo was favorable.

Manufacturer Narrative

H10.Additional manufacturer narrative: updated section b5.

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.

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: 8734847
• MDR Text Key: 149260029
• Report Number: 2015691-2019-02342
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/13/2019

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: 09/03/2022
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 06/27/2019; 07/01/2019; 07/23/2020
• Supplement Dates FDA Received: 07/01/2019; 07/03/2019; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR