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

Model Number 9600TFX23

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problem Low Cardiac Output (2501)

Event Date 11/28/2022

Event Type  Injury  

Event Description

As reported, it was a case of an implant of 23mm edwards sapien 3 transcatheter heart valve, in aortic position by transfemoral approach.The valve was fully deployed at the intended position; however, post-dilatation was needed due to moderate pvl.During post-dilatation, the 23mm sapien 3 valve move into the left ventricle.Another valve was implanted due to low cardiac output.On post-operative day 1, the first valve was explanted.No patient injury.Patient outcome was good post-procedure.It was noted that the valve was deformed due to post-dilatation.

Manufacturer Narrative

The investigation is ongoing.The device is not returning.

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2022-10293.

Manufacturer Narrative

Correction to section h6.The valve was not returned to edwards lifesciences for evaluation.In addition, no relevant imagery was provided for review.A device history review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.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.A review of the risk management documentation was performed, and 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 complaints were unable to be confirmed as no imagery/medical record was provided for evaluation.A review of dhr did not indicate any manufacturing nonconformance that could have contributed to the reported event.A review of ifu/training materials revealed no deficiencies.It was reported ''the balloon guidewire was wrongly positioned through valve cells instead of valve lumen resulting in valve embolization when the balloon was inflated.The valve was deformed due to post-dilatation''.Due to the post-dilation at the incorrect position, the valve frame was deformed, and disloged; subsequently, it was push toward the ventricle resulting in embolization.Available information suggests that procedural factors (post-dilation with incorrect guidewire position) may have contributed to the reported events.Since no manufacturing non-conformances or labeling/ifu/training deficiencies were identified, no product non-conformance was confirmed, and the complaint occurrence rate did not exceed the applicable trending control limit, no corrective/preventative actions nor product risk assessment (pra) escalation are required.

• Brand Name: SAPIEN 3 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: 16017018
• MDR Text Key: 305833062
• Report Number: 2015691-2022-10179
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600TFX23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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