MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 8300AB

Device Problems Gradient Increase (1270); Difficult to Open or Close (2921); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/12/2021

Event Type  Injury  

Manufacturer Narrative

There can be several root causes of leaflet immobility or leaflet restriction.There may be cases where the leaflet or leaflets are not functioning as intended leading to regurgitation.Technique-related factors such as suture looping, where the surgeon inadvertently loops a suture over one of the commissural posts, may restrict leaflet motion.Similarly, leaflet restriction can also be caused by chordae entrapment when subvalvular apparatus sparing technique is utilized.Like suture looping, chordae entrapment can contribute to central regurgitation and may require reoperation.Another technique-related issue is valve distortion during implant which may result in a dropped leaflet or asymmetric coaptation.The subject device is not available for evaluation as it was discarded by the site.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, an appropriate investigation will be performed.

Event Description

Through implant patient registry, it was learned that a patient with a 23mm 8300ab aortic valve was explanted after an implant duration of three years, seven months due to severe stenosis, and leaflet motion restricted.The explanted valve was replaced with a 23mm 11500a valve.Per the idc, there was a deficiency in the original device.Per the medical records, the patient presented with failed bioprosthetic aortic valve and cad.The patient underwent a redo aortic valve replacement and aortic root patch enlargement and cabg x2.The existing valve was removed, and a root enlargement was performed with a bovine pericardial patch.The explanted valve was replaced with a 23mm 11500a valve.Echo demonstrated aortic valve gradient improvement.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.

Manufacturer Narrative

H10: additional manufacturer narrative: updated section: h6 (device code(s).H11: corrective data: corrected section: h6 (investigation findings and investigation conclusions).

• Brand Name: EDWARDS INTUITY ELITE AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12147723
• MDR Text Key: 261356490
• Report Number: 2015691-2021-04044
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

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: 06/06/2021
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 07/09/2021
• Supplement Dates Manufacturer Received: 08/19/2021
• Supplement Dates FDA Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR