MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SAPIEN 3 ULTRA RESILIA 26MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9755RSL26J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 06/28/2023

Event Type  Death  

Manufacturer Narrative

Per the instructions for use (ifu), heart failure is a known potential adverse event associated with the thv procedure and the use of the edwards thv devices.Heart failure is when the heart is unable to pump sufficiently to maintain blood flow to meet the body's needs.Signs and symptoms commonly include shortness of breath, excessive tiredness, and leg swelling.The shortness of breath is usually worse with exercise, while lying down, and may wake the person at night.A limited ability to exercise is also a common feature.Chest pain, including angina, does not typically occur due to heart failure.Common causes of heart failure include coronary artery disease including a previous myocardial infarction (heart attack), high blood pressure, atrial fibrillation, valvular heart disease, excess alcohol use, infection, and cardiomyopathy of an unknown cause.These cause heart failure by changing either the structure or the functioning of the heart.There are two main types of heart failure: heart failure due to left ventricular dysfunction and heart failure with normal ejection fraction depending on whether the ability of the left ventricle to contract is affected, or the heart's ability to relax.The severity of the disease is usually graded by the degree of problems with exercise.Heart failure is not the same as myocardial infarction or cardiac arrest.Other diseases that may have symptoms similar to heart failure include obesity, kidney failure, liver problems, anemia, and thyroid disease.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.The exact cause of the reported event could not be determined, however, investigation results suggest that factors/mechanisms mentioned above could have caused or contributed to this event.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

Event Description

As reported through the japanese tavi registry reporting system, the patient underwent a transfemoral (tf) transcatheter aortic valve replacement (tavr) and received a 26 mm sapien 3 ultra resilia (s3ur) valve.After the tavr, the patient was diagnosed with secondary myelofibrosis and transferred to another hospital.Approximately 2 months after the tavr, the patient passed away due to a heart failure during hospitalization in another hospital.

• Brand Name: SAPIEN 3 ULTRA RESILIA 26MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 19181730
• MDR Text Key: 341044964
• Report Number: 2015691-2024-03143
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140031
• 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
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9755RSL26J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Death
• Patient Sex: Male