MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX26

Device Problems Failure to Align (2522); Failure to Advance (2524); Malposition of Device (2616)

Patient Problems Calcium Deposits/Calcification (1758); Injury (2348)

Event Date 07/25/2019

Event Type  Injury  

Manufacturer Narrative

The valve was not returned to edwards lifesciences for evaluation, as it remains implanted in the patient.Per the instructions for use (ifu), valve 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 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 valve leaflets and cause central aortic insufficiency; it can obstruct the coronary ostia; and lead to embolization of the prosthesis into the ascending aorta.    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, there was no allegation or indication a device malfunction contributed to this adverse event.  per report, the valve malposition was likely caused by patient factors (calcium on the right and left cusps) and procedure factors (wire biasing the right curvature and the physician had difficulty aligning the 3 cusps in one plane).  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 the edwards affiliate in (b)(6), during a transfemoral tavr procedure, the 26 mm sapien 3 valve/commander delivery system had difficulty crossing the native annulus.  the wire was biasing the right curvature and the physician had difficulty aligning the 3 cusps in one plane. additionally, there was calcium in the right and left cusp, making it difficult to align the valve. on inflation, the physician realized the valve was positioned in a too aortic position and attempted to advance the valve more ventricular but encountered resistance.  once the valve was deployed, the physicians were concerned for the stability of the valve and opted to deploy a second valve.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9118332
• MDR Text Key: 162469488
• Report Number: 2015691-2019-03560
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• 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: 09/04/2019

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: 03/18/2021
• Device Model Number: 9600TFX26
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 11/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR