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

Model Number 9750TFX

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Insufficient Information (4580)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

Exemption number e2016006, this report summarizes 1 event of mitral valve reintervention the sapien 3 ultra transcatheter heart valve in the mitral position.The ¿time to event¿ (tte, in days) for this event was 0.The device identification (di) numbers for edwards sapien 3 ultra transcatheter heart valve are: (b)(4).Intra-procedural and in-hospital mitral valve re-intervention will typically result from valve malposition or regurgitation (pvl or central, including leaflet restriction).These conditions are known potential risks associated with the use of the thv, delivery system, and/or accessories.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve malposition, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, characteristics of the pre-existing valve or ring, loss of pacing capture, rapid deployment, release of stored tension during deployment, and movement of the delivery system by the operator.Valve malposition has the potential to contribute to suboptimal coaptation of the thv valve leaflets and cause central aortic insufficiency; it can lead to migration or embolization of the prosthesis.Physicians are extensively trained by edwards before they are qualified to use the 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, specific procedural details are not available to determine potential contributing factors.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

This report summarize 1 event of mitral valve reintervention serious injury events for the sapien 3 ultra transcatheter heart valve in the mitral position for august 2020.The age range for this event is 85.The breakdown for gender is as follows: 1 female.August 2020 data extract includes data provided by acc for q1 (january 1 and march 31).

Manufacturer Narrative

Supplemental report to add noe statement in b5 section, and provide d5 and h6 information.

Event Description

This report summarize event of mitral valve reintervention serious injury events for the sapien 3 ultra transcatheter heart valve in the mitral position for (b)(6) 2020.

• Brand Name: EDWARDS SAPIEN 3 ULTRA
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10890584
• MDR Text Key: 218943318
• Report Number: 2015691-2020-14643
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9750TFX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other