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 Code Available (3191)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.The device history record (dhr) was unable to be reviewed as the device serial number was not provided.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.A definitive root cause could not be determined.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards received notification that a valve of unknown size was explanted approximately 6 hours after the implant due to paravalvular leak (pvl).No other information was provided.

Manufacturer Narrative

Device evaluation: customer report of pvl could not be confirmed through visual observations.X-ray demonstrated wireform intact and frame expanded.Leaflet 1 had a non-transmural leaflet tear approximately 5mm long near commissure 2 on the outflow aspect.Fibrin on the stent circumference was minimal on the outflow aspect.No other visible inconsistencies were observed on the valve.A suture hole was visible near one of the three black stitch markings on the sewing ring.

Manufacturer Narrative

Device evaluation: customer report of pvl could not be confirmed through visual observations.X-ray demonstrated wireform intact and frame expanded.Leaflet 1 had a non-transmural leaflet damage approximately 5mm long near commissure 2 on the outflow aspect.Host tissue on the stent circumference was minimal on the outflow aspect.No other visible inconsistencies were observed on the valve.A suture hole was visible near one of the three black stitch markings on the sewing ring.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: 8981374
• MDR Text Key: 161242256
• Report Number: 2015691-2019-03377
• 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: 08/19/2019

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: 08/09/2022
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/10/2019
• Supplement Dates Manufacturer Received: 09/19/2019; 12/05/2019; 07/23/2020
• Supplement Dates FDA Received: 10/02/2019; 12/10/2019; 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention