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

Model Number 11500AJ

Device Problems Fluid/Blood Leak (1250); Material Perforation (2205); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 02/18/2022

Event Type  Injury  

Manufacturer Narrative

The device was returned to edwards for evaluation as is pending evaluation.A supplemental mdr will be submitted once the product evaluation is complete or additional information is received.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.

Event Description

Edwards received information that a 21mm 11500aj aortic pericardial valve, implanted approximately six (6) months, was explanted due to aortic regurgitation.The device was originally implanted for minimally invasive cardiac surgery aortic valve replacement to correct aortic stenosis.The device was explanted and replaced with an sjm mechanical valve with no patient adverse events reported.The patient status was reported as recovered.The device was returned for evaluation.There was no allegation of device malfunction.Patient age at implant: (b)(6).The doctor commented that the leaflet was perforated by a cor-knot, resulting in the aortic regurgitation, and this event was not device related.

Manufacturer Narrative

H10.Additional manufacturer narrative: the complaint is confirmed.An edwards/supplier manufacturing defect is not confirmed.If the surgeon does not cut sutures close to the knot, excess suture tails may result in abrasion, perforation, or damage to the leaflet.This may require an exchange of the device.Based on the information available, the cor-knot came into contact with the leaflet causing a suture tail abrasion.The most likely cause is procedural factors.Pannus overgrowth, or host tissue, is considered to be a form of non-structural valve dysfunction.The growth of host tissue on the sewing ring is expected and is a natural part of the healing reaction to prosthesis implantation.Pannus can have both beneficial and harmful effects depending on the amount of growth.A small amount of host tissue growth over the suture line is needed to form a non-thrombogenic surface and complete the healing process after valve implantation.In contrast, if there is an excessive amount of pannus growth, it can extend onto the cusp surfaces leading to thickening of the cusps, leaflet immobility, elevated gradients, and stenosis.Host tissue growth can also contribute to cusp retraction or curling resulting in valvular regurgitation.Host fibrous (pannus) tissue growth is not a malfunction of the device.

Manufacturer Narrative

A perforation, approximately 2mm x 2mm wide, was observed on leaflet 3.The perforation was beveled at the outflow aspect, a typical characteristic of those caused by suture tail/fastener abrasion.No sutures remained attached to the sewing ring around leaflet 3.Serrated mechanical damage marks were also observed on the outflow surface of leaflet 3.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 8 mm on leaflet 3 at the inflow aspect.Host tissue overgrowth on the stent circumference was moderate at the outflow aspect and minimal at the inflow aspect.The x-ray demonstrated the wireform around leaflet 3 was bent outward and the v fit cocr alloy band was not expanded.Wireform was exposed on commissure 3 and around leaflets 1 and 3 on the inflow aspect.Customer report of regurgitation was confirmed through observed leaflet perforation.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13860581
• MDR Text Key: 287681509
• Report Number: 2015691-2022-04560
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2022

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 Operator: Health Professional
• Device Expiration Date: 01/06/2023
• Device Model Number: 11500AJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 04/11/2022; 05/25/2022
• Supplement Dates FDA Received: 05/07/2022; 05/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Female