MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM AORTIC VALVE; REPLACEMENT HEART VALVE

Model Number 8300AB25

Device Problems Leak/Splash (1354); Perivalvular Leak (1457); Positioning Problem (3009)

Patient Problems Aortic Regurgitation (1716); Death (1802)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Paravalvular leak (pvl) refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue.It may occur as a result of a lack of appropriate sealing of the valve at the annulus.The most common reason for pvl is inadequate debridement of a calcified annulus or attempted implant with improper valve seating.Pvl is not a result of device malfunction.In this case, it was reported the patient was left on balloon pump and ecmo.The patient was reported to have expired and the pvl and valve contributed to the event.No additional details were provided.The root cause remains indeterminable.A supplemental report will be submitted upon product evaluation completion and device history records review completion.

Event Description

It was reported that a 25mm pericardial aortic valve was explanted at implant due to perivalvular leak (pvl) and improper seating.A 25mm pericardial aortic valve was implanted.The patient left on a balloon pump and ecmo.The patient was reported to have expired.It was also noted that the pvl and valve contributed to the event.It was reported that this was the surgeon's first eie case.This was an avr+cabg case.The patient had tricuspid valve; hockey stick approach and sizers 23mm, 25mm, and 27mm were used; the shape of the native annulus was round; normal debridement was performed; simple suture technique was employed.Seating was very easy.A gap was noticed after delivery system was removed and a pledget suture was used.When clamp was removed the lv kept filling up and echo was performed.Based on the evaluation of the echo showing a pvl (prior to protamine administration) with low flow and the filling of the lv.The surgeon opted to remove the valve and replace it.

Manufacturer Narrative

Customer report of "pvl and improper seating" could not be confirmed through visual observations.The x-ray demonstrated wireform intact and frame expanded.A suture hole was visible near one of the black stitch markings on the sewing ring.The holder and balloon introducer were returned connected to each other, and detached from the valve.The delivery system was also returned; no visible inconsistencies were observed.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.

Manufacturer Narrative

Reference capa: 20-00141.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM AORTIC VALVE
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8217736
• MDR Text Key: 132202266
• Report Number: 2015691-2019-00059
• 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,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2022
• Device Model Number: 8300AB25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• 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
• Patient Age: 85 YR