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

Model Number 9300TFX23A

Device Problems Malposition of Device (2616); Device-Device Incompatibility (2919)

Patient Problem Not Applicable (3189)

Event Date 10/14/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).At this time, the thv is not indicated for use inside a native mitral valve, and there is no guidance in the thv training manual on usage of a sapien xt valve within a mitral valve.Testing performed by edwards documents the phenomena of high placement of the thv in a native aortic annulus, which would be relevant in the scenario of a thv in a mitral valve, as well.Inaccurate deployment (too high or too low in the mitral valve) could result in clinically significant hemodynamic compromise, implantation of a second valve, embolization of the valve, and/or may require additional intervention to secure or remove the valve.In this case, the exact cause of the malposition of the initial valve cannot be confirmed.It is possible that procedural factors (miscommunication during the initial valve positioning and deployment) may have contributed to this event.

Event Description

During a trans-septal valve-in-valve (sapien xt in an existing bioprosthetic mitral ring) procedure, a 23mm sapien xt was placed too atrial, approximately 90:10 atrial/ventricular.Due to concerns about possible valve migration, a second sapien xt valve was deployed to anchor the initial valve.Minimal paravalvular leak (pvl) was observed post valve deployment.The procedure was completed and the patient was transferred in stable condition.At the time of this report, the patient was doing well.It was speculated that possible miscommunication during the initial valve positioning and deployment contributed to this event.No device issues were reported.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 5196066
• MDR Text Key: 30203321
• Report Number: 2015691-2015-02932
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2016
• Device Model Number: 9300TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2015
• Date Device Manufactured: 01/15/2015
• 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): Required Intervention
• Patient Age: 82 YR