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

Model Number 8300AB23J

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 03/18/2022

Event Type  Injury  

Manufacturer Narrative

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

Edwards learned that a 23mm 8300ab pericardial aortic valve, implanted for fifteen (15) days was explanted due to paravalvular leak secondary to undersizing.The device was originally implanted for aortic valve replacement (mics-avr) to correct aortic stenosis and regurgitation.The echo after implant was not clear but did not show the symptom of pvl.Eleven (11) days after the implant, pvl was seen and it suddenly got aggravated.The device was explanted, the patient annulus was re-sized and replaced with a bigger size 25mm non-edwards valve with no adverse patient events reported.The patient status was reported as "under treatment".The device will not be returned for evaluation as it was discarded by the hospital.The surgeon commented that "there was a sizing error at implant.It was undersized." there was no allegation of device malfunction.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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 or improper seating.The most common reason for pvl is inadequate debridement of a calcified annulus and is not a result of device malfunction.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• 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 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 14119096
• MDR Text Key: 289347575
• Report Number: 2015691-2022-05140
• Device Sequence Number: 1
• Product Code: LWR
• 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: Foreign,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

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 Model Number: 8300AB23J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 05/20/2022
• Supplement Dates FDA Received: 05/21/2022
• Date Device Manufactured: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 91 KG