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

Model Number 9750TFX

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/01/2022

Event Type  Injury  

Event Description

Thv/tvt registry summary reporting for adverse event submission for quarter 3 2022 data extract for mitral serious injury events for the sapien 3 ultra valve.This report summarizes 1 left ventricular outflow tract obstruction serious injury events for the sapien 3 ultra transcatheter heart valve.The age range for this event is 70 years.The breakdown for gender is as follows: 1 male.

Manufacturer Narrative

This report provides data from thv/tvt registry exemption number e2016006 and summarizes 1 left ventricular outflow tract obstruction serious injury events for the sapien 3 ultra transcatheter heart valve in the mitral position.The "time to event" (tte, in days) for this event was 4.The device identification (di) numbers for edwards sapien 3 ultra transcatheter heart valve are: 00690103201314, 00690103201321, 00690103201338.Per the instructions for use, valve malposition requiring intervention is a potential adverse event associated with the use of transcatheter heart valves.Obstruction of the left ventricular outflow tract can be caused by patient factors (anterior mitral leaflet protruding into the lvot, septal bulge) 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 explantation 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 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 product malfunction contributed to this adverse event.Specific clinical and procedural details are not available to determine potential contributing factors to the event, or if the event is related to an edwards device.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.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15591984
• MDR Text Key: 301630544
• Report Number: 2015691-2022-08403
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Exemption Number: E2016006
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9750TFX
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 70 YR