MAUDE Adverse Event Report: EDWARDS LIFESCIENCES UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

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

Patient Problem Heart Failure (2206)

Event Date 12/01/2015

Event Type  Injury  

Manufacturer Narrative

This is seven of eight manufacturer reports being submitted for this case.The dates of the events are unknown; however, according to the article the study period was from december 2015 to december 2018.For this reason, the first day of the reported study period ((b)(6) 2015) was used as the occurrence date.In this case, the exact valve model number is not available.Therefore, this report will reflect an unknown edwards sapien transcatheter heart valve.The possible pma numbers associated with an edwards sapien transcatheter heart valves are:  p110021- edwards sapien transcatheter heart valve; p130009 - edwards sapien xt¿ transcatheter heart valve; p140031- edwards sapien 3 transcatheter heart valve and edwards sapien 3 ultra heart valve.Please reference article: uchida, yasuhiro, et al."impact of skeletal muscle mass on clinical outcomes in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement." cardiovascular intervention and therapeutics (2020): 1-9.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 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 deficiency malfunction contributed to this adverse event.Based on the limited information provided in the article, the cause of the heart failure is unknown.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

Event Description

As reported by an edwards lifesciences affiliate in (b)(6) through review of article ¿impact of skeletal muscle mass on clinical outcomes in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement¿ regarding a  single-center study conducted on 71 consecutive patients who underwent tavr for symptomatic severe aortic stenosis from december 2015 to december 2018.The following clinical outcomes were note in table 3: during the postoperative period 7 patients were hospitalized due to heart failure.Details of the events was not provided.

Manufacturer Narrative

Please reference related manufacturer report no: (b)(4).

• Brand Name: UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10905616
• MDR Text Key: 218913364
• Report Number: 2015691-2020-14709
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization