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

Model Number 8300AB

Device Problem Device Stenosis (4066)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 06/28/2023

Event Type  Injury  

Manufacturer Narrative

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.Engineering evaluation summary: stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potentials known and unknown patient-related contributing factors.Per technical summary 33069, rev a, structural valve deterioration (svd) is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, non-structural valve dysfunction (nsvd) may also play a role in the development of valvular stenosis.Stenosis is most commonly related to patient factors and is not usually an indication of a device malfunction related to a manufacturing deficiency.Devices implanted 5 years or greater with calcification, dehiscence, leaflet tears, thickened leaflet, pannus, or structural valve deterioration (stenosis, regurgitation) reported as the complaint do not require an engineering evaluation.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.A capa/scar/pra is not required as there are no confirmed product or labeling non-conformances and no other triggers are met.The most likely cause is patient factors, including history of hyperlipidemia (hld) and coronary artery disease (cad).All pertinent information available to edwards lifesciences has been submitted.

Event Description

It was reported and learned through medical records that a patient with a 25mm 8300ab aortic valve in aortic position underwent a valve in valve procedure after an implant duration of five (5) years, three (3) months and 23 days due to severe aortic stenosis.The patient was presented with acute on chronic chf, nyha 111.Tavr procedure was completed with a non-edwards transcatheter valve and patient was discharged home on pod# 7 in stable condition.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18509771
• MDR Text Key: 332880500
• Report Number: 2015691-2024-00393
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194500
• UDI-Public: (01)00690103194500(17)210826
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2024

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: 08/26/2021
• Device Model Number: 8300AB
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2017
• 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: 76 YR
• Patient Sex: Male