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

Model Number 9750TFX26

Device Problem Material Deformation (2976)

Patient Problem Perforation of Vessels (2135)

Event Date 10/24/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted upon completion.This is one of three manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2022-09425 and 2015691-2022-09426.

Event Description

Edwards received notification from our affiliate in germany.As reported, this was a case of an implant of 26mm edwards sapien 3 ultra transcatheter heart valve, in the aortic position by transfemoral approach.During the procedure, when it was advancing the delivery system through the esheath, it was extremely difficult and required a lot of force.It seemed that the sheath was torn open and the sapien 3 ultra valve was pushed through the esheath distal tip and perforated part of the vessel.There was no lateral exit of the delivery system through the esheath.For commander delivery system with the crimped valve and esheath removal, it was needed to perform a surgical cutdown.Upon inspection of the retrieved devices, no damaged was found on the device.The patient was operated on no valve was implanted.As per the pre-decontamination evaluation, the valve was found to have one bent strut.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The returned device was visually inspected for any abnormalities and the following was observed: the crimped thv valve was over the delivery system inflation balloon area.One (1) strut bent outward at valve outflow side.The thv valve was expanded and the valve frame was distorted/canted.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.The complaint of valve frame damage was confirmed based on returned device.A review of the dhr, lot history, complaint history, and manufacturing mitigation did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.As reported, ''during procedure, when it was pushing the catheter through the esheath, it was extremely difficult and required a lot of force.It seems that the sheath was torn open (liner punctured) and the sapien 3 ultra valve was pushed through the esheath and, then perforated part of the vessel.For commander delivery system with the crimped valve and esheath removal, it was needed to perform a cutdown''.Additionally, the patient's access vessel had presence of calcification and tortuosity.The presence of calcification and tortuosity can create challenging pathway during delivery system withdrawal, leading to resistance.Device evaluation revealed bent struts at outflow and the crimped valve appeared moved to the inflation balloon, which may suggest excessive device manipulation during system withdrawal.Excessive force applied to manipulate the device can lead to the valve struts interacting with the sheath shaft and resulted in strut damage at the outflow during retrieval.As such, available information suggests that patient factors (calcification, tortuosity) and/or procedural factors (excessive device manipulation, withdrawal of crimped valve) may have contributed to the complaint 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 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: 16018980
• MDR Text Key: 305872593
• Report Number: 2015691-2022-10186
• 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: 02/27/2023

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 Expiration Date: 02/03/2024
• Device Model Number: 9750TFX26
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2022
• 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
• Patient Sex: Female