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

Model Number 3300TFX23MM

Device Problems Degraded (1153); Fluid/Blood Leak (1250); Perivalvular Leak (1457); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 08/31/2023

Event Type  Injury  

Manufacturer Narrative

H10: additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Event Description

Through implant patient registry it was learned that a 23mm 3300tfx valve in the aortic position, was explanted after an implant duration of 4 years, 8 months due to unknown reason.The explanted valve was replaced with a 25mm 3300tfx valve.

Manufacturer Narrative

The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Event Description

Through implant patient registry it was learned that a 23mm 3300tfx valve in the aortic position, was explanted after an implant duration of 4 years, 8 months due to mildly thickened leaflets, degeneration, severe regurgitation, and pvl.The explanted valve was replaced with a 25mm 3300tfx valve.Per medical records, the patient presented with sob, pedal edema.The patient underwent redo-avr with a 25mm magna ease valve,and cabg.The patient was transported to icu in critical condition post procedure and discharged on pod#11.

Manufacturer Narrative

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 device malfunction related to a manufacturing deficiency.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regards 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 history of coronary artery bypass graft (cabg), hyperlipidemia (hld), chronic kidney disease (ckd) and coronary artery disease (cad).

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA 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; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17959112
• MDR Text Key: 325968759
• Report Number: 2015691-2023-16891
• Device Sequence Number: 1
• Product Code: DYE
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2023

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: 05/24/2022
• Device Model Number: 3300TFX23MM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 10/18/2023; 11/28/2023
• Supplement Dates FDA Received: 11/10/2023; 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2018
• 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: 77 YR
• Patient Sex: Male