MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS; REPLACEMENT HEART VALVE

Model Number 7300TFXJ

Device Problems Calcified (1077); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Device Stenosis (4066)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2024

Event Type  Injury  

Event Description

It was reported that a 25mm 7300tfxj mitral valve was explanted after an implant duration of five (5) years, ten (10) months for prophylactic purpose during aortic valve replacement surgery.The patient status was reported as 'under treatment'.Per the customer, the patient presented with dyspnea on effort due to moderate aortic regurgitation and required intervention, while the degree of mitral regurgitation was trivial and did not require intervention at this point.This mitral valve replacement was simultaneously performed with the aortic valve replacement for reasons of durability of the device and surgical strategy.Upon the valve explant, slight pannus and calcification were observed.

Manufacturer Narrative

Evaluation summary: customer reported valve was explanted prophylactically was unable be confirmed.X-ray demonstrated wireform intact.X-ray demonstrated heavy calcification on leaflets 1 and 2.Calcification restricted leaflet mobility and led to stenosis.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 3mm on leaflet 3 on the inflow aspect and 5mm on leaflet 3 on the outflow aspect.Host tissue fused leaflets 1 and 3 by approximately 2mm at commissure 1, leaflets 1 and 2 by approximately 3mm at commissure 2, and leaflets 2 and 3 by approximately 3mm at commissure 3 on the outflow aspect.Subvalvular apparatus was observed around the sewing ring around leaflet 1.Sewing ring was partially cut off around the valve and exposed the metal band.Cut off sewing ring fragment was not returned with valve.Additional manufacturer narrative: the reported event was not confirmed through preliminary evaluation of the explanted valve.The reported event is pending final evaluation analysis.A supplemental report will be submitted accordingly once the evaluation has been completed.

Manufacturer Narrative

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 root cause of this event was determined to be due to patient related factors.The calcification observed in this case was due to a progression of the patient's underlying valvular disease pathology combined with the patient's other underlying risk factors, including a history of chronic kidney disease (ckd) and dialysis.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.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.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18794389
• MDR Text Key: 336394923
• Report Number: 2015691-2024-01402
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057/S068
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: 7300TFXJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2016
• 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; Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male