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

Model Number 11500A

Device Problems Gradient Increase (1270); Leak/Splash (1354); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problems Corneal Pannus (1447); Aortic Valve Stenosis (1717); Hemorrhage/Bleeding (1888); Organ Dehiscence (2502)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).The device was not returned to edwards for evaluation as it was discarded.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.The clinical observation was confirmed.Stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient related contributing factors.Svd, a common reason for bioprosthesis explant or reoperation, encompasses multiple failure modes, including calcific and non-calcific 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, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.Host tissue is a complex process triggered by the interaction between the host and the device and is highly variable among patients.Literature defines pannus as a type of scarring and tissue ingrowth.It is not currently possible to predict the occurrence and severity for any given patient with a bioprosthetic heart valve.A certain degree of host tissue growth is expected.Since the mechanism of host tissue growth in bioprosthetic heart valves is still not fully understood.The cause of the event cannot be determined; however, patient factors and progression of patient's underlying valvular disease may have contributed to the event.If additional information is received a supplemental mdr will be submitted.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 a 25mm aortic valve was explanted after an implant duration of four (4) months due to paravalvular leak (pvl), dehiscence, and pannus.Patient was transferred to hospital for further management of endocarditis.Test results were negative for infection.The aortic valve dehisced corresponding to two thirds of the circumference.The patient also underwent aortic root replacement, tricuspid valve repair with an edwards tricuspid ring, and mitral valve repair with non-edwards 29mm band.The explant device was replaced with a 26mm homograft.Patient was transferred to cvicu at the conclusion of the surgery.Surgical pathology noted bovine pericardial bioprosthetic material with pannus formation.Surgical pathology test results for infection came back negative and patient was stopped on antibiotics.Patient was discharged home in stable condition on post-operative day 10.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa: 20-00141.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• 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 92614
• MDR Report Key: 10402819
• MDR Text Key: 203120810
• Report Number: 2015691-2020-13071
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2021
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 42 YR