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

Model Number 11500A

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

Patient Problems Chest Pain (1776); Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 11/16/2022

Event Type  Injury  

Event Description

It was reported that a patient with a 11500a 27mm aortic valve, implanted for 2 years, 9 months, exhibited calcification.A tavr was performed with a 29mm 9600tfx valve without complication.

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.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections: b5, b7, d4 (expiration date), h2, h4, h6 (clinical code, type of investigation, investigation findings, and investigation conclusions).The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.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 device malfunction.The most likely cause is patient factors, including hyperlipidemia.

Event Description

It was reported that a patient with a 11500a 27mm aortic valve, implanted for 2 years, 9 months, exhibited calcification.The patient presented with shortness of breath, and chest pain.A tavr was performed with a 29mm 9600tfx valve without complication.The patient is stable.

Manufacturer Narrative

H10: additional manufacturer narrative: updated: b4, b5, g3, g6, h2, h6.

Event Description

It was reported that a patient with a 11500a 27mm aortic valve, implanted for 2 years, 9 months, exhibited degeneration, severe stenosis, and regurgitation.The patient presented with class 3 chf, shortness of breath, and chest pain.A tavr was performed with a 29mm 9600tfx valve without complication.The patient discharged home on pod #1.Internal echo review showed evidence of structural valve deterioration with probably anatomically mild prosthetic as but hemodynamically moderate lv outflow obstruction.

Event Description

It was reported that a patient with a 11500a 27mm aortic valve, implanted for 2 years, 9 months, exhibited calcification, severe stenosis, and regurgitation.The patient presented with class 3 chf, shortness of breath, and chest pain.A tavr was performed with a 29mm 9600tfx valve without complication.The patient discharged home on pod #1.

Manufacturer Narrative

The most likely cause is patient factors, including hyperlipidemia and stage 3 chronic kidney disease (ckd 3).

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 15942702
• MDR Text Key: 305099397
• Report Number: 2015691-2022-09748
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103195002
• UDI-Public: (01)00690103195002(17)240730
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male