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

Model Number 9600TFX29

Device Problems Failure to Align (2522); Device Dislodged or Dislocated (2923)

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

Event Date 02/23/2020

Event Type  Injury  

Manufacturer Narrative

The valve was not returned to edwards lifesciences, as it remains implanted in the patient.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 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 embolization (i.E.Minimal leaflet calcification, severe septal hypertrophy), bav may provide indication of potential balloon movement during valve deployment.In this case, per report, the valve embolized into the aorta due to procedural factors (alignment difficulty).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 france, during a transfemoral tavr procedure, the operator had difficulty aligning the valve and attempted to deploy the 29mm sapien 3 valve.The valve embolized into the ascending aorta and a second valve had to be deployed in the annulus.Initially the physician reported having difficulty while trying to align (fine and gross) the 29mm sapien 3 valve exactly between the markers.The patient was reported to have a highly tortuous anatomy and the physician aligned the valve in a straighter section.Although the valve alignment issue was not resolved, the decision was made to proceed with valve deployment.During deployment, the valve ¿jumped¿ backwards into the ascending aorta and was not fully deployed.The valve was pulled back and anchored in a part of the ascending aorta.A new 29mm sapien 3 valve was then prepped and implanted in the annulus.The patient was reported to be doing fine after the procedure.The patient¿s iliacs/aorta were reported to have a moderate degree of calcification and tortuosity.Note: this description summary pertains to the first deployed valve.

Manufacturer Narrative

Section h10: this is one of two reports being submitted for this case.Please reference manufacturer report no.2015691-2020-11219.

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; one edwards way; irvine CA 92614
• MDR Report Key: 9894970
• MDR Text Key: 190350981
• Report Number: 2015691-2020-11218
• 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,Followup
• Report Date: 03/03/2020

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: 09/17/2021
• Device Model Number: 9600TFX29
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/28/2020
• Supplement Dates Manufacturer Received: 03/28/2020; 07/23/2020
• Supplement Dates FDA Received: 03/28/2020; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention