MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN XT TRANSCATHETER HEART VLV (23MM); AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9300TFX23

Device Problems Failure to Capture (1081); Malposition of Device (2616); Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

Patient Problems Calcium Deposits/Calcification (1758); Embolism (1829); Left Ventricular Hypertrophy (1949); Injury (2348)

Event Date 12/07/2018

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), valve malposition requiring intervention and valve embolization are 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 or bulky/severely calcified aortic leaflets, preserved ejection fraction, significant mitral annular calcification (mac), loss of pacing capture, rapid deployment, release of stored tension during deployment, and movement of the delivery system by the operator.Deployment of the sapien valve too aortic has the potential to contribute to suboptimal coaptation of the sapien xt valve leaflets and cause central aortic insufficiency; it can obstruct the coronary ostia; and lead to embolization of the prosthesis into the ascending aorta.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 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 xt 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.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, the device is not available for evaluation as it remains implanted in the patient.However, there was no allegation or indication a device malfunction contributed to this adverse event.Per the physician, the valve malposition and resulting embolization was likely due to small ventricle pushing up on the device, high output low pressure ventricle, heavy calcification of the native valve and annulus, or momentary loss of capture during deployment.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 by our affiliates in (b)(6), during deployment of a 23mm sapien xt valve in the aortic position via transfemoral approach, the valve landed too aortic in a 90:10 aortic/ventricular position.The valve then embolized into the aorta.A second valve was implanted and the first valve was snared and stented in the descending aorta.At the time of the report the patient was stable.As per medical opinion, the valve moved too aortic possibly due to small ventricle pushing up on the device, high output low pressure ventricle, as a result of the position of the heavy calcification of the native valve and annulus, or momentary loss of capture during deployment.The patient¿s native annulus area measured 298mm2 and the annular diameter measured 16x23mm by ct.The native annulus, native leaflets, and aortic root were severely calcified.The patient had moderate ventricular septal hypertrophy.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VLV (23MM)
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8191000
• MDR Text Key: 131205905
• Report Number: 2015691-2018-05527
• 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
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2019
• Device Model Number: 9300TFX23
• 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: 89 YR