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

Model Number 3300TFXJ19

Device Problems Degraded (1153); Gradient Increase (1270); Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)

Event Date 04/01/2023

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.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 information that a patient with a19mm 3300tfx pericardial aortic valve was hospitalized for very severe aortic stenosis (as) and mild paravalvular leak secondary to structural valve deterioration after an implant of approximately two (2) years and nine (9) months.A symptom of dyspnea on exertion was seen.While hospitalized, the patient went into cardiopulmonary arrest (cpa) and balloon aortic valvuloplasty (bav) was performed while the patient was on extracorporeal membrane oxygenation (ecmo).Ecmo was weaned off, however, percutaneous cardiopulmonary support (pcps) was introduced for worsening of heart failure symptoms due to as.The patient underwent valve in valve procedure with a 20mm sapien 3 urtra while the patient was on pcps.The patient's status was reported as "under treatment in icu".A 72- year-old female with a medical history of chronic renal failure, chronic dialysis (since 17 years ago), s/p aortic valve replacement (avr) to correct as and coronary artery bypass graft (cabg).

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.The most likely cause is patient factors, including chronic dialysis and history of coronary artery bypass graft (cabg).

• 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: 17171817
• MDR Text Key: 317632777
• Report Number: 2015691-2023-14060
• 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
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

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 Model Number: 3300TFXJ19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/29/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 08/03/2023
• Supplement Dates FDA Received: 08/04/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 40 KG