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

Model Number 9000TFX26A

Device Problems Leak/Splash (1354); Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problem Aortic Insufficiency (1715)

Event Date 06/27/2014

Event Type  Injury  

Event Description

During the transaortic tavr procedure, the valve embolized into the ventricle.The patient¿s annulus was measured 24mm by tee, and 22mmx30mm by ct, with an area of 560mm² by ct.There were additional measurements of 520 and 560mm², and the leaflets were heavily calcified.The annulus was between a 26mm sapien and 29mm sapien xt.The physician elected to go with a 26mm valve after balloon sizing with a 25 x 4cm balloon.The native aortic valve had bulky calcification.The valve was positioned 40:60 aortic/ventricular, however, during deployment the valve shifted and was deployed in a 20:80 a/v position, with severe central aortic insufficiency and one paravalvular jet.The physician elected to do a valve in valve.When they attempted to cross the first thv with the second thv, they embolized the first valve into the ventricle.At that point they elected to put the patient on bypass and convert the patient to an open avr.They pulled the first valve out of the ventricle during the open procedure, and the second valve was pulled out with the sheath.The patient did very well and was noted to be in stable condition.The 20/80 (a/v) placement of first thv without a good seal in annulus as the sizing was very borderline and possibly undersized.The image intensifier angle was noted to be good, coaxial alignment of the delivery system and valve was fair, ventilation was held and there was no loss of pacing capture during valve deployment.

Manufacturer Narrative

Per the instructions for use, device malposition, regurgitation and embolization requiring intervention are known potential adverse events associated with the tavr procedure.Per the instructions for use (ifu), device malposition requiring intervention is a known potential complication 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 ventricular malposition, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, a narrow, calcified sinotubular junction, minimally or severely calcified aortic leaflets, loss of pacing capture, and movement of the delivery system by the operator.Malposition has the potential to contribute to suboptimal coaptation of the sapien valve leaflets and cause central aortic insufficiency.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 ventricular malposition (i.E.Small, calcified stj, minimal leaflet calcification), bav may provide indication of potential balloon movement during valve deployment.In this case, per report, the 20/80 (a/v) placement of the first thv without a good seal in the annulus was attributed to the borderline and possibly undersized valve.The first valve embolized when the physician attempted to cross the malpositioned valve with the second valve.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 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: deborah deutsch ; 1 edwards way; irvine, CA 92614 ; 9497564213
• MDR Report Key: 3941627
• MDR Text Key: 4534666
• Report Number: 2015691-2014-01609
• 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: 06/27/2014

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: 04/11/2015
• Device Model Number: 9000TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2014
• Initial Date FDA Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2013
• 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: 83 YR
• Patient Weight: 82