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

Model Number 9300TFX26

Device Problems Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993); No Pacing (3268)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2020

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), valve embolization 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 embolization, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, severe septal hypertrophy, minimally or bulky/severely calcified aortic leaflets, preserved ejection fraction, loss of pacing capture, rapid deployment, release of stored tension during deployment, and movement of the delivery system by the operator.The edwards thv patient screening manual advises the operator on pre-procedure assessment of the aortic valve and root, taking into consideration the degree and distribution of native leaflet calcification.The procedural didactic instructs 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 transcatheter heart valve (thv).Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.The correct sizing, alignment and positioning of the device are emphasized as key factors to the placement and fixation of the device.There may be cases in which the valve is not able to be deployed at the intended location.This may require deploying the valve at a non-target location.Although, generally well tolerated, the long-term effects are not completely understood.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.  the cause of the reported event cannot be confirmed, however, procedural factors (loss of pacing during deployment) most likely contributed to the valve embolization and deployment in the ascending aorta.Other potential contributing factors are unknown as limited clinical information was provided.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

As reported from our affiliates in (b)(6), during a transfemoral tavr procedure with a 26mm  sapien xt valve in the aortic position, pacing capture was lost during valve deployment and the valve was not fully deployed in the annulus.  the valve was post dilated and secured in the ascending aorta.  a second 26mm xt valve was implanted in the annulus.  the patient was stable post procedure.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9886000
• MDR Text Key: 193674627
• Report Number: 2015691-2020-11154
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2020
• Device Model Number: 9300TFX26
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR