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

Model Number 9000TFX26

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 12/12/2013

Event Type  Injury  

Event Description

It was reported through the implant patient registry (ipr) that two 26mm sapien valves were implanted.No additional information was provided.Additional information provided by the edwards field clinical specialist indicates that during the transapical tavr procedure, upon deployment, the sapien valve ¿jumped¿ aortic and ended up in a 90:10 aortic position.The tee demonstrated the bottom of the valve to be sitting on the annulus: however, a mild pvl was noted.The physicians decided to deploy another sapien valve more ventricular to make sure the first valve was stabilized and to correct the pvl.A second 26 ascendra delivery system was then advanced and the valve was placed 60:40 aortic and remained in this position post deployment.The post deployment tee demonstrated good position and trace pvl.During post operative discussion, the physicians noted that deployment inflation was done too fast and they were not able to correct for the movement of the valve during deployment.Additional information noted there was mild native valve/leaflet calcification.The aortic root calcification and mitral annular calcification (mac) severities are unknown.The image intensifier angle and coaxial alignment of delivery system and valve were reported to be good.Ventilation was held and there was no loss of pacing capture during valve deployment.

Manufacturer Narrative

Per the instructions for use, device malposition requiring intervention is a known potential adverse event associated with the transcatheter aortic valve replacement (tavr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to aortic malposition, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, severe septal hypertrophy, minimally calcified aortic leaflets, preserved ejection fraction, and loss of pacing capture.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 patients with high-risk anatomical features for aortic malposition (i.E.Minimal leaflet calcification, severe septal hypertrophy), bav may provide indication of potential balloon movement during valve deployment.In this case the exact cause of the event could not be confirmed; however patient (minimal leaflet calcification) and procedural factors (fast inflation) could have caused or contributed to the too aortic deployment of the valve and resulting regurgitation.This event was resolved with implantation of a second valve in a more ventricular position.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: SAPIEN 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: deborah deutsch ; 1 edwards way; irvine, CA 92614 ; 9497564213
• MDR Report Key: 3567534
• MDR Text Key: 4072757
• Report Number: 2015691-2014-00083
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2013

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: 02/11/2015
• Device Model Number: 9000TFX26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2013
• Initial Date FDA Received: 01/10/2014
• Date Device Manufactured: 09/05/2013
• 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: 85 YR