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

Model Number 11500A

Device Problems Gradient Increase (1270); Difficult to Open or Close (2921); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 09/27/2021

Event Type  Injury  

Manufacturer Narrative

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.The device was returned and product evaluation is ongoing.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Event Description

Edwards received information that a 19mm aortic pericardial valve, implanted approximately one (1) year and ten (10) months, was explanted due to aortic stenosis secondary to leaflet immobility caused by pannus growth.The device was explanted and replaced with a non-edwards valve with no adverse events.The patient status was reported as recovered.The doctor commented that this explant was device related.

Manufacturer Narrative

H10: additional narratives.Updated d4, h4, and h6 per new information received.The root cause of this event cannot be conclusively determined.However, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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

H3: device evaluated by manufacturer : customer reports of stenosis, leaflet immobility, and pannus growth were confirmed.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 10mm on leaflet 2 at the inflow aspect.Host tissue overgrowth on the stent circumference was minimal at the outflow aspect.Host tissue overgrowth restricted leaflet mobility and led to stenosis.All three leaflets were swollen along the free margin near commissures 1 and 2.Wireform was exposed on commissures 1 and 3.Serrated mechanical damage marks were observed on the outflow surfaces of leaflets 1 and 3 at commissure 1.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.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: gail warner ; one edwards way; mailstop 6.1 anton; irvine, CA 92614 ; 9492504096
• MDR Report Key: 12682601
• MDR Text Key: 278426105
• Report Number: 2015691-2021-05868
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103198867
• UDI-Public: (01)00690103198867(17)201106
• 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: 12/21/2021

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: 11/06/2020
• Device Model Number: 11500A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 11/01/2021; 12/20/2021
• Supplement Dates FDA Received: 11/23/2021; 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2018
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female