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

Model Number 9600TFX29

Device Problems Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

As reported by our affiliate in spain, during a transfemoral tavr procedure, a 29mm sapien 3 valve was deployed in the aortic position.The valve was deployed in a final 20:80 aortic/ventricular (a/v) position.A mechanical ¿monoplate valve¿ was noted to be present in the mitral valve prior to the tavi.Shortly after the successful implantation of the sapien 3 valve, it was noted that the mechanical mitral valve was ¿blocked¿ and did not work ¿appropriately¿.The procedure was converted to open surgery and the sapien 3 and mitral valves were explanted.Surgical biologic valves were then implanted.Information regarding the native annular diameter and degree of valvular calcification was not provided.Per medical opinion, the mechanical valve likely got ¿blocked¿ after the deployment of the sapien 3 valve.However, it was also possible that a thrombus could have contributed to the event.

Manufacturer Narrative

Per the instructions for use (ifu), valve 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 (stj), minimally or bulky/severely calcified aortic leaflets, 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 3 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.Per the instructions for use (ifu), potential risks associated with the overall procedure include thrombus formation, plaque dislodgment, and embolization that may result in myocardial infarction, stroke, distal peripheral occlusion, and/or death.It is the natural tendency of the body to form clot on foreign objects in the vascular space.These patients are anticoagulated for the procedure and interventional best practices mandate meticulous wiping and flushing of the devices to prevent and/or remove clot.The thv training manuals and ifu instruct the operator to administer heparin and maintain the act at = 250 sec.In this particular case, despite multiple investigational attempts, it was not possible to obtain additional details regarding the case.Although there is insufficient information to determine the cause of the post sapien 3 complication, too ventricular placement of the sapien 3 valve and/or possible thrombus may have contributed to the complication with the mechanical mitral valve and subsequent explant of the sapien 3 and mitral valves.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.

Manufacturer Narrative

Corrected data: f10, h6.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; 1 edwards way; irvine CA 92614
• MDR Report Key: 9247827
• MDR Text Key: 164248269
• Report Number: 2015691-2019-03999
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2021
• Device Model Number: 9600TFX29
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 83 YR