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

Model Number 11500A21

Device Problems Fluid/Blood Leak (1250); Gradient Increase (1270); Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it remains implanted.Attempts to retrieve 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.

Event Description

Edwards reviewed article use of the inspiris valve in the native right ventricular outflow tract is associated with early prosthetic regurgitation.J thorac cardiovasc surg.2023 apr 22:s0022-5223 (23)00342-2.Doi: 10.1016/j.Jtcvs.2023.04.018.Epub ahead of print.Pmid: 37088131.A 21mm 11500a inspiris resilia aotic valve was implanted in native rvot and was found to have at least moderate restricted leaflet motion pulmonary regurgitation and pulmonary stenosis after implant duration of eight (8) months.Patient underwent tpvr with 18mm melody non-edwards transcatheter valve.The patient was eight-year-old at time of implantation of the 21mm 11500a valve with history of double outlet right ventricle and tetralogy of fallot.

Manufacturer Narrative

Added information to h6.Complaint is confirmed via literature article.Based on the information available, the device was intentionally used outside the way it was designed and intended (off-label use).The performance, safety, efficacy, longevity, and durability of rings and bioprosthetic valves have not been determined when the product is used outside the scope of its intended use and/or its studied population.The device was not returned for evaluation and dhr review was unable to be performed as no serial number was provided.Edwards conducts manufacturing and inspection tests to ensure optimum functionality of each valve prior to final distribution.Such tests used to evaluate if edwards valves meet specification include forward flow testing to determine the pressure gradient across the open valve and a coaptation test under constant hydrostatic back pressure to visually evaluate the coaptation of the leaflets.Leaflet immobility or leaflet restriction occurring over time can be attributed to structural valve deterioration and/or nonstructural dysfunction, which can be manifested as regurgitation and/or stenosis.Nonstructural valve dysfunction (nsvd) is any abnormality not intrinsic to the valve itself that results in dysfunction of the prosthetic valve.The term nsvd refers to problems that do not directly involve valve components yet results in dysfunction of the prosthetic valve; such problems can include entrapment by pannus, tissue, or suture, malposition, patient prosthesis mismatch, thrombosis, or technical errors.Structural valve deterioration (svd) can also lead to chronic central leaks over a period of time.Based on the information available, a definitive root cause cannot be concluded but patient factors, including history of congenital heart disease (tetralogy of fallot and double outlet right ventricle) and implant position, could have contributed.

• 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
• 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: 17066632
• MDR Text Key: 316575768
• Report Number: 2015691-2023-13449
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2023
• 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): Life Threatening; Required Intervention; Hospitalization