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

Model Number 9600TFX26J

Device Problems Premature Activation (1484); Malposition of Device (2616)

Patient Problems Injury (2348); Complete Heart Block (2627)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

This is one of three manufacturer reports being submitted for this case.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 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.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The exact cause of the placement of the valve too ventricular, and subsequent need for a valve in valve procedure, is unknown but most likely due to the unexpected pushing of the delivery system balloon during valve positioning or deployment.The tension may have been a result of patient factors (horizontal aorta and mild vessel tortuosity).A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.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 (b)(6) affiliate, during a tf tavr procedure the delivery system balloon catheter was locked during valve positioning.The valve did not move on the balloon.The delivery system balloon was unexpectedly pushed to the left ventricular side while attempting to deliver the valve and the valve was deployed in a 10:90 (aortic/ventricular) position, which was lower than intended.The physician believes some tension might have been accumulated in the system and it released during valve positioning or deployment.A 2nd valve was implanted in the 1st valve to prevent embolization.The patient developed complete av block and left the operating room with temporary pacing.The patient received a permanent pacemaker on postoperative day 6.His condition is stable and there are no problems with valve function.

Manufacturer Narrative

Please reference related manufacturer report nos :2015691-2020-10847 and 2015691-2020-10849.

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: 9802051
• MDR Text Key: 188362242
• Report Number: 2015691-2020-10846
• 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: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2021
• Device Model Number: 9600TFX26J
• Device Lot Number: 6845634
• 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: 83 YR