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

Model Number 11500A

Device Problems Degraded (1153); Gradient Increase (1270); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 08/25/2023

Event Type  Injury  

Manufacturer Narrative

H10.Additional manufacturer narrative: the device was not returned to edwards for evaluation as it remains implanted.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 notification that a 13 year old patient with a 11500a23 valve implanted in the aortic position underwent a valve-in-valve procedure after approximately four (4) years due to an infection and valve degeneration.As reported, the patient presented in a very poor condition and a 23mm transcatheter valve was implanted within the surgical device.The implantation went well with very good outcome.Post op.The patient was doing fine.

Event Description

Edwards received notification that a 13 year old patient with an 11500a23 valve implanted in aortic the position underwent a valve-in-valve procedure after approximately four (4) years due to valve degeneration leading to moderate stenosis, thrombus formation, severely impaired function of a systemic right ventricle with dilatation of the right systemic ventricle.The patient presented in a very poor condition, gastroenteritis combined with start of clinical deterioration, blue lips, needing oxygen, fever, diarrhea and vomiting due to the gastro-intestinal infection.As reported, the infection did not lead to endocarditis.A 23mm transcatheter valve was implanted within the surgical device via transfemoral approach.The implantation went well with very good outcome.Post operatively the patient was doing fine.

Manufacturer Narrative

H10: additional manufacturer narrative: a device history record (dhr) review was performed, and no relevant non-conformances were identified.The device was not returned to edwards lifesciences for further investigation, as the valve remains implanted, and no medical records or images were provided.Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.Structural valve deterioration (svd) can, and typically does, lead to chronic central leaks over a period of time.Svd is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Degeneration-related structural deterioration is most commonly related to patient factors and is not usually an indication of a manufacturing non-conformance.The most likely root cause is patient factors, including the patient's age at the time of implant and their congenital heart defect (hypoplastic left heart syndrome).Thrombosis is a well-recognized complication of prosthetic devices.Device thrombosis is the formation of blood clots forming on the device/graft.These clots could significantly impact the function of the valve resulting in harm.There may be cases of incidental finding by imaging (echocardiography and/or ct scan) of subclinical leaflet thrombosis (halt) where the patient will benefit from a close follow-up and may be treated with oral anticoagulant.The most likely root cause is patient factors.Based on the information available, the most likely root cause is patient factors.There is no evidence to suggest an edwards manufacturing defect.No remedial action/corrective action/preventive action/field safety corrective action (fsca) is needed.

• 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; mle fl2 office m2013; irvine, CA 92614
• MDR Report Key: 17779742
• MDR Text Key: 323790258
• Report Number: 2015691-2023-16053
• 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
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2019
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 13 YR
• Patient Sex: Male