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

Model Number 9750TFX23

Device Problem Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/12/2023

Event Type  Injury  

Event Description

Edwards received notification from our affiliate in germany.As reported, this was a case of an implant of a 23mm sapien 3 ultra in the aortic position by transfemoral approach.During the procedure, the esheath was inserted via right femoral artery.A temporary pacemaker lead via left femoral vein was positioned into rv apex.Testing capture <2v.The valve was in position for implant with position marker on base of cusps.Rapid pacing with 180 beats/min was initiated.While deploying the valve, and the valve was half opened, there was a loss of capture of the pacemaker.The next pacemaker non capture embolized the valve towards the ascending aorta.The embolized valve was retrieved towards the descending thoracic aorta and was implanted.The pacemaker lead was positioned new with additional capture testing and rapid pacing test.In the meantime, a new 23mm sapien 3 ultra kit valve was prepared, and the valve was implanted without problems.Patient condition is good.The root cause of the valve embolization was due to loss of pacing capture.The root cause of the valve embolization was the ppm capture loss.

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 of 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.As reported, ''while deploying the valve, and the valve was half opened there was a loss of capture of the pacemaker.The next pacemaker non capture embolized the valve towards ascending aorta.Embolized valve was retrieved towards descending thoracal aorta.The root cause of the valve embolization was the ppm capture loss''.Per the instructions for use (ifu), valve embolization is a known potential adverse event associated with the transcatheter valve replacement (thv) procedure.In this case it was reported ''there was a loss of capture of the pacemaker''.Per training manual, ''loss of capture during rapid pacing can cause sudden delivery system movement during deployment'', which could cause the delivery system (with valve) to move toward aorta resulting in embolization.

• 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: 16293554
• MDR Text Key: 308743968
• Report Number: 2015691-2023-10547
• 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: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9750TFX23
• Device Catalogue Number: N/A
• Device Lot Number: 9675075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2022
• 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