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

Model Number 11500A

Device Problems Calcified (1077); Fluid/Blood Leak (1250); Gradient Increase (1270)

Patient Problem Dyspnea (1816)

Event Date 10/18/2023

Event Type  Injury  

Manufacturer Narrative

H10: additional manufacturer narrative: the subject device is not available for evaluation as it remains implanted in the patient.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 reported 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 patient with a 11500a21 valve implanted in pulmonic position underwent a valve-in-valve procedure after three (3) years and ten (10) months due to calcific degeneration leading to stenosis and regurgitation.The patient presented with shortness of breath before the reintervention.A 23mm transcatheter valve was successfully implanted within the edwards surgical device.The patient was discharged home.

Manufacturer Narrative

Added information to section d4 (expiration date), h4 (device manufacturer date), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions) 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."edwards received notification that a patient with a (b)(4), valve implanted in pulmonic position underwent a valve-in-valve (viv) procedure after three (3) years and ten (10) months due to calcific degeneration leading to stenosis and regurgitation." based on the information available, the device was intentionally used outside the way it was designed and intended.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.Calcific degeneration is a common cause of bioprosthetic heart valve failures.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valve's hemodynamic performance, and glutaraldehyde fixation of tissue.Of these, the fixation process is a relatively minor contributor to calcification for edwards' tissue valves due to anti-calcification treatments during manufacturing.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent bioprostheses from calcifying.Calcification is most commonly related to patient factors and is not usually an indication of a manufacturing non-conformance.Based on the information available, the most likely cause is patient factors, including implant position and patient's age at time of implant.There is no evidence to suggest an edwards manufacturing defect.

• 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 ; one edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18117014
• MDR Text Key: 327879610
• Report Number: 2015691-2023-17441
• 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: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2023
• 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: 12/08/2023
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 12 YR
• Patient Sex: Female