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

Model Number 9750TFX20

Device Problem Migration (4003)

Patient Problem Foreign Body Embolism (4439)

Event Date 08/21/2023

Event Type  Injury  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Per the instructions for use (ifu), valve embolization is a known potential adverse event associated with the transcatheter valve replacement (thv) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to embolization of the device, including improper positioning before deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, severe septal hypertrophy (in aortic position), minimally or bulky/severely calcified leaflets, preserved ejection fraction, loss of pacing capture, rapid deployment, the release of stored tension during deployment, and inaccurate measurement of the landing zone, a landing zone with an elliptical shape, and valve under or oversizing.The ifu cautions that incorrect sizing of the valve may lead to paravalvular leak, migration, or embolization.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 (all models).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 in 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 embolization, a balloon valvuloplasty may indicate potential balloon movement during valve deployment.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate that severe calcification of the existing bioprosthetic valve and effective orifice area (eoa) or the valve could have caused or contributed to this event.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 this adverse event 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 monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.H3 other text : device not returned.

Event Description

As reported by our european affiliates, during implant of a 20mm sapien 3 ultra (s3u) valve in aortic position by transfemoral approach within pre-existing non-edwards surgical valve, the bioprosthesis presented severe calcification and the patient had a very challenging anatomy with high risk of sinus sequestration.During the procedure, the alignment was unproblematic but it was impossible to pass through the pre-existing bioprosthesis valve.A last attempt led to complete hemodynamic collapse with a phase of reanimation and extracorporeal membrane oxygenation (ecmo) support.It was decided to attempt it again, which resulted in the complete removal of the delivery system since the implant wire was out of the left ventricle.The system was withdrawn into the esheath and removed as a single unit without difficulties.During implantation of the new 20mm s3u valve with previous balloon aortic valvuloplasty (bav), the valve embolized to the aorta.The procedure was moved to a surgical intervention to remove the embolized valve and for an aortic valve replacement.The patient was noted as to have a successful removal of the embolized valve and aortic valve replacement (avr).

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from received from a follow up.The previously submitted investigation remains the same.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 17737502
• MDR Text Key: 323292288
• Report Number: 2015691-2023-15895
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9750TFX20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention