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

Model Number SAPIEN VALVE UNKNOWN

Device Problems Degraded (1153); Fluid/Blood Leak (1250); Leak/Splash (1354); Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Regurgitation (1716); Mitral Regurgitation (1964); Tricuspid Regurgitation (2112); Stenosis (2263)

Event Date 11/29/2019

Event Type  Injury  

Manufacturer Narrative

Bibliography: shinichi fukuhara, m.A.(2020).Surgical explantation of transcatheter aortic bioprostheses: results and clinical implications.Journal of thoracic cardiovascular surgery, 1-10.Per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves.Paravalvular leak refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue, as a result of a lack of appropriate sealing of the valve to the target site.Some pvl is not uncommon post deployment.Many cases are mild to moderate, and either resolve over time or do not cause symptoms.Others may be more clinically significant and require intervention.The mechanism behind worsening or late pvl is not well understood but may be related to cardiac remodeling.Calcification is a well-recognized failure mode of bioprosthetic valves.The mechanism of calcification of biomaterials is not completely understood but is probably related to an inability of the non-viable cells to maintain their normally low intracellular concentration of calcium.Calcific degeneration is a common cause of bioprosthetic heart valve failures.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valve¿s performance, and glutaraldehyde fixation of tissue.Of these, the fixation process is a relatively minor contributor to calcification for edwards' tissue valves due to anti-calcification treatments during manufacturing.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent bioprostheses from calcifying.In this case, the cause of the worsening pvl at 5.3 years cannot be determined; however, cardiac remodeling may have been a factor.In addition, the cause for the calcification at explant could not be confirmed; however, it may be due to patient factors in combination with the progression of pre-existing aortic valve disease.Other potential contributing factors are unknown as limited clinical information was provided in the article.There was no allegation or indication a product deficiency contributed to this adverse event.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

A single-center retrospective study was published in a journal article, ¿surgical explantation of transcatheter aortic bioprostheses: results and clinical implications¿.The study was between april 28, 2011 and june 30, 2019, in which tavr explantation was performed in 15 patients.In addition, 2 patients from outside institutions also underwent tavr explantation.Clinical details were reviewed of these 17 patients.One patient who received a sapien valve approximately 5.3 years later presented with severe symptomatic paravalvular leak (pvl) and the valve was explanted.Three patients with a sapien 3 valve had their valves explanted: one patient with a 29mm sapien 3 with end stage renal disease on hemodialysis developed structural valve degeneration and severe aortic stenosis, severe mitral regurgitation and severe tricuspid regurgitation (tr).The second patient with a 29mm sapien 3 valve explanted presented with severe pvl, vsd and severe tr.The third patient with a 23mm sapien 3 valve explanted presented with structural valve degeneration with severe as.All three patients received a surgical aortic valve replacement.This complaint represents the sapien valve explant at approximately 5.3 years, in which the patient presented with severe pvl.A surgical aortic valve replacement was implanted.

Manufacturer Narrative

This report is 1 of 4 being submitted for this complaint.Reference mfg.Report numbers 2015691-2020-11188, and 2015691-2020-11191 and 2015691-2020-11197.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: 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: 9889353
• MDR Text Key: 192038305
• Report Number: 2015691-2020-11186
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P110021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SAPIEN VALVE UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR