MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN XT TRANSCATHETER HEART VLV (26MM); PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9300TFX26

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

Patient Problems Death (1802); Occlusion (1984); Obstruction/Occlusion (2422)

Event Date 09/06/2018

Event Type  Injury  

Manufacturer Narrative

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 xt 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, the device is not available for evaluation as it remains implanted in the patient.There was no allegation or indication a device malfunction contributed to this adverse event.As reported, the lvot obstruction was likely caused by the anterior native mitral leaflet protruding into the lvot.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 by our affiliates in (b)(4), during implant in the mitral position, the sapien xt valve was deployed in an excellent position, however, a calcific part of anterior native mitral leaflet moved and occluded part of the left ventricular outflow tract (lvot).The patient expired a few minutes later.The patient was in a ¿critical situation¿ prior to the tavr procedure.The patient had a pre-existing non-edwards valve in the aortic position.

Manufacturer Narrative

The valve was implanted via transapical approach.The patient¿s native annulus measured 4.337cm2.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VLV (26MM)
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7928224
• MDR Text Key: 122451504
• Report Number: 2015691-2018-04008
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2018
• Device Model Number: 9300TFX26
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/02/2018
• Supplement Dates Manufacturer Received: 10/16/2018; 07/23/2020
• Supplement Dates FDA Received: 10/23/2018; 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR