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

Model Number 9600TFX29

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/24/2023

Event Type  Injury  

Event Description

Edwards received notification from our affiliate in canada.As reported, this was a case of 29mm sapien 3 valve implant, in the aortic position by transfemoral approach.During the valve deployment, the 29mm sapien 3 valve embolized towards the aorta due to loss of pacing capture the valve was implanted in the descending aorta.Therefore, a second 29mm sapien 3 valve was implanted in the intended position.The patient outcome was good.As per medical opinion, the root cause of the event was the loss of pacing capture.

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion.Device remained implanted.

Manufacturer Narrative

The device was not returned for evaluation as it remained implanted.Therefore, a no product return engineering evaluation was performed.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 complaint valve embolized into aorta was unable to be confirmed as no imagery/ medical record was provided for evaluation.There was no allegation or indication a device malfunction contributed to this adverse event.Therefore, no device history record or lot history are required.A review of ifu/training materials revealed no deficiencies.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 aortic embolization, including improper positioning before deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, severe septal hypertrophy, minimally or bulky/severely calcified leaflets, preserved ejection fraction, loss of pacing capture, rapid deployment, the release of stored tension during deployment, and movement of the delivery system by the operator.As reported, ''during procedure, during the valve deployment due to loss of pacing capture the 29mm sapien 3 valve embolized towards the aorta.The valve was implanted in the descending aorta.'' in this case, the loss of pacing capture caused the valve to jump into the aorta.Per training manual, loss of pacing capture during valve deployment could lead to ''sudden movement during deployment'' resulting in valve embolized into the aorta as reported.As such, available information suggests that procedural factors (loss of pacing capture) may have contributed to the reported event.No device or labeling problem was identified during the evaluation.Therefore, no further escalation (capa/scar/pra) is required.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.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEATH 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: 16397567
• MDR Text Key: 309784376
• Report Number: 2015691-2023-10919
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2024
• Device Model Number: 9600TFX29
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2022
• 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