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

Model Number 11500A23

Device Problems Degraded (1153); Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 07/09/2021

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: bioprosthetic tissue valves can deteriorate with time and eventually fail contributing to regurgitation and/or stenosis.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Leaflet tears and leaflet disruptions occurring over time are a form of structural valve deterioration (svd) that may ultimately result in significant regurgitation requiring replacement of the valve.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.The subject device was not returned for evaluation.If returned and evaluated a supplemental report with findings will be submitted.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 23mm 11500a pericardial aortic valve underwent a redo aortic valve replacement after an implant duration of three (3) years, two (2) months due to a hole in the valve.The replacement valve is unknown.No additional information provided.

Manufacturer Narrative

H10: additional manufacturer narrative: updated: b4, d4, g3, g6, h2, h4, h6 the root cause of this event cannot be determined with the available information.However, this event was most likely impacted by the progression of the patient's underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.

• Brand Name: INSPIRIS RESILIA 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: gail warner ; 1 edwards way; irvine, CA 92614 ; 9492504096
• MDR Report Key: 12599632
• MDR Text Key: 277650884
• Report Number: 2015691-2021-05570
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 09/15/2019
• Device Model Number: 11500A23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2021
• Date Device Manufactured: 09/15/2017
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male