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

Model Number 8300AB

Device Problems Perivalvular Leak (1457); Detachment of Device or Device Component (2907)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 12/10/2022

Event Type  Injury  

Manufacturer Narrative

The subject device is not available for evaluation, as it remains implanted in the patient.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that a patient with a 25mm 8300ab aortic valve, implanted for 4 years, 2 months, underwent a valve-in-valve procedure due to dehiscence.The patient was treated for a high-risk pci with impella support.During the attempt to place the impella, the wire and subsequently the impella were placed through the dehiscence rather than through the intuity.The pci was completed.When the position of the impella was realized, concern was noted that perhaps the frame of the intuity may have been bent by the impella.After the pci, the intuity was wired with a supportive wire, the impella was removed from the dehiscence, but severe pvl noted on echo.Attempts were made to dilate the intuity with a high pressure balloon to reduce the dehiscence and pvl.Unable to reduce the pvl by balloon dilation alone, the team deployed a 29mm 9600tfx valve within the intuity.The patient was sent to recovery in stable condition.

Manufacturer Narrative

The device history record 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.Valve dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate prosthetic valve implantation in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease.Valve dehiscence is not a malfunction of the device.Through further investigation, it was determined that the root cause of this event was most likely due to patient related factors.

Event Description

It was reported and learned through investigation that a patient with a 25mm 8300ab aortic valve, implanted for 4 years, 2 months, underwent a valve-in-valve procedure due to dehiscence and severe pvl.The patient presented with acute on chronic heart failure.The tavr procedure was completed successfully with a 29mm sapien 3 transcatheter valve.The patient was discharged from the hospital on pod# 8.The patient is s/p avr and cabg in 2018.He recently presented with chest discomfort and acute on chronic heart failure.Cardiac workup revealed severe pvl and severe cad.The patient underwent an impella supported pci.It was noted that the impella device was going through the pvl defect.Impella was removed and the patient was taken to the hybrid or to do an emergent tavr and pvl repair.The surgical valve was dilated via a 28mm true balloon and pvl improved to mild-moderate.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16097136
• MDR Text Key: 306643359
• Report Number: 2015691-2023-09957
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194500
• UDI-Public: (01)00690103194500(17)220124
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2022
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Male