MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number SAPIEN 3 UNKNOWN

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Bibliography: open transcatheter valve implantation for mitral annular calcification: one-year outcomes.Ui hamid, a gregg, p ball, c owens, g manoharan; jtcvs; 2021, elsevier.Lvot obstruction in patients who undergo transcatheter mitral valve replacement is a well-recognized postoperative complication.In most cases of postoperative lvot obstruction, the obstruction results from the protrusion of the valve into the lvot or from abnormal subvalvular positioning of the prosthesis.Additionally, lvot obstruction may occur postoperatively if there is a narrowed mitral-aortic angle, or due to a thickened interventricular septum.Other possible causes include a hyper contractile left ventricle or atrial fibrillation.Obstruction of the left ventricular outflow tract can also be caused by patient factors (anterior mitral leaflet protruding into the lvot) or procedural factors (positioning of the valve frame within the annulus).Depending on the degree of obstruction, cardiac output and hemodynamic stability may be affected.Inaccurate deployment is generally a result of use error or a combination or patient and procedural factors.In some cases lvot obstruction could result in clinically significant hemodynamic compromise that may require explanation of the thv with surgical correction.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Physicians are extensively trained by edwards before they are qualified to use the sapien 3 thv.Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.The correct alignment and positioning of the device at the point of deployment is emphasized as a key factor to the placement and fixation of the device.Operators are also instructed to use fluoroscopy as the primary method of visualization for positioning and deployment.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The cause for the lvot obstruction could not be determined with the information provided by the authors.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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, through a single-center study published in a european journal article 'open transcatheter valve implantation for mitral annular calcification: one-year outcomes1.The retrospective analysis of patients was from 2017 to 2020 referred for transcatheter mitral valve implant (tmvi).Demographic characteristics details, surgical strategy, perioperative complications, and hospital stay including 30-day and 1-year mortality were analyzed.The study included use of the edwards sapien 3 transcatheter valve in the mitral position.This complaint is for a 57-year-old female patient who underwent a transcatheter mitral valve implantation of a sapien 3 valve in mitral annular calcification and underwent a concomitant procedure of an aortic valve repair.The patient developed a left ventricle obstruction (lvot) during the procedure.Consequently, the anterior mitral leaflet was excised, and the prosthesis was oriented away from the lvot with a higher implant.The patient is stable.

Manufacturer Narrative

This supplemental mdr is being submitted for reference of manufacturer report numbers.This report is 4 of 5 being submitted for this complaint.Reference mfg.Report numbers 2015691-2022-10188, 2015691-2022-10190, 2015691-2022-10191, and 2015691-2022-10194.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, 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: 16019297
• MDR Text Key: 305873100
• Report Number: 2015691-2022-10193
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SAPIEN 3 UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 57 YR
• Patient Sex: Female