MAUDE Adverse Event Report: EDWARDS LIFESCIENCES THV VALVE UNKNOWN; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number VALVE UNKNOWN

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

Patient Problem Heart Failure (2206)

Event Date 01/01/2014

Event Type  Death  

Manufacturer Narrative

Article reference: medranda, giorgio a., kunal brahmbhatt, kevin marzo, khaled salhab, richard schwartz, and stephen j.Green."outcome of patients having transcatheter mitral valve implantation for the treatment of degenerated mitral bioprostheses." the american journal of cardiology (2020).It was unknown which valve the patient¿s received, sapien xt or sapien 3 valves.The pma numbers are p130009 and p140031, respectively.The dates of the events are unknown; however, according to the article the study period was from 2014 to 2019.For this reason, the first day of the reported study period (01-jan-2014) was used as the occurrence date.Per the instruction for use (ifu), heart failure is a potential risk associated with aortic valve replacement and bioprosthetic heart valves.Congestive heart failure can have multiple etiologies and is often due to the progression of underlying disease processes, including coronary artery disease, uncontrolled hypertension, myocardial infarction, cardiomyopathy, fluid overload, or valvular dysfunction.Risk factors that increase a patient¿s risk of suffering from chf include obesity, advanced age, and a history of smoking.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The cause for the heart failure could not be determined with the information provided by the authors.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

Per the journal article, ¿outcome of patients having transcatheter mitral valve implantation for the treatment of degenerated mitral bioprostheses¿, a retrospective, observational study was performed of 26 patients with prior surgical mitral valve replacement or mitral valve repair with annular ring that underwent tmvi using the balloon-expandable sapien xt or sapien 3 heart-valve system at our institution from 2014 to 2019.Of the 26 patients, 20 had prior surgical mitral valve replacement and 6 had prior repair with annular ring.The primary indication for tmvi was bioprosthetic mitral regurgitation in 9 patients, bioprosthetic mitral stenosis in 9 patients and mixed mitral disease in 8 patients.Tmvi was performed through the transseptal approach in 19 patients and through the transapical approach in 7.There was a 100% device implantation success rate.During the study period, one (1) patient expired within 30 days of the procedure.The patient was readmitted for acute on chronic decompensated heart failure with cardiogenic shock refractory to inotrope.

Manufacturer Narrative

This is one of four manufacturer reports being submitted for this case.Please reference related manufacturer report numbers: 2015691-2020-13400, (b)(4), 2015691-2020-13402, 2015691-2020-13404.

• Brand Name: THV VALVE UNKNOWN
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10480464
• MDR Text Key: 205243849
• Report Number: 2015691-2020-13400
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VALVE UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death