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

Model Number 7300TFX

Device Problems Calcified (1077); Gradient Increase (1270); Perivalvular Leak (1457); Insufficient Information (3190)

Patient Problems Chest Pain (1776); Dyspnea (1816); Dizziness (2194); Insufficient Information (4580)

Event Date 02/14/2024

Event Type  Injury  

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

It was reported that a patient with a 29mm 7300tfx mitral valve, implanted for six (6) years, nine (9) months, has been placed underwent evaluation for a valve-in-valve procedure due to unknown reason.

Event Description

It was reported that a patient with a 29mm 7300tfx mitral valve, implanted for six (6) years, nine (9) months, has been placed underwent evaluation for a valve-in-valve procedure due to calcification, severe mitral stenosis, and moderate perivalvular leak.The patient presented with shortness of breath, chest pain, and dizziness.A re-intervention is planned.

Event Description

It was reported that a patient with a 29mm 7300tfx mitral valve, implanted for six (6) years, nine (9) months, underwent a valve-in-valve procedure due to calcification, severe mitral stenosis and moderate perivalvular leak.The patient presented with shortness of breath, chest pain, and dizziness.The procedure was performed with a 29mm 9600tfx valve.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections: b2, b5, b7, d4 (expiration date), g3, g6, h2, h4, h6 (impact code, type of investigation, investigation findings, and investigation conclusions).The device history record (dhr) review was completed and there were two non-conformances found related to this serial number.However, the valve was re-worked to completion, passing all inspections.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 related to a manufacturing deficiency.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.The most likely cause is patient factors, including a history of hyperlipidemia (hld).

• 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18849660
• MDR Text Key: 337036740
• Report Number: 2015691-2024-01649
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00690103186277
• UDI-Public: (01)00690103186277(17)201005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2020
• Device Model Number: 7300TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2016
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Male