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

Model Number 8300AB19

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported a 19mm 8300ab aortic valve was explanted after unknown implant duration due to patient prosthesis mismatch.It was reported the 19mm 8300ab aortic valve was too small.

Manufacturer Narrative

The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information is in process.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 events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

Image evaluation: reports of patient prothesis mismatch and sizing issues were unable to be confirmed through image evaluation.Two color photos were provided; one photo was of valve outflow aspect and one photo was of valve inflow aspect.Valve frame appeared expanded but pushed inward around one of the leaflets.Valve appeared to have host tissue overgrowth encroaching over the frame.

Manufacturer Narrative

Added information to h6.Patient prosthesis mismatch (ppm) is present when the effective orifice area of the inserted prosthetic valve is too small in relation to body size.Its main hemodynamic consequence is to generate higher than expected gradients through a normally functioning prosthetic valve.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17674025
• MDR Text Key: 322546889
• Report Number: 2015691-2023-15686
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2023

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 Model Number: 8300AB19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 09/01/2023
• Supplement Dates Manufacturer Received: 09/11/2023; 10/28/2023
• Supplement Dates FDA Received: 10/04/2023; 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Life Threatening; Required Intervention