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

Model Number 9750TFX23

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 01/17/2023

Event Type  Injury  

Event Description

During a tavr procedure using a 23mm sapien 3 ultra valve via transfemoral approach, during inflation, the commander delivery system balloon did not inflate.When the atrion device was pulled negative, blood was seen in the device, indicating balloon damage.During the withdrawal of the devices, the esheath was able to be pulled out but a cutdown was necessary to remove the catheter with the valve from the patient.A second valve was prepared and implanted successfully.The patient suffered bleeding in the femoral vein when trying to close the femoral artery and a vascular surgeon was called.The patient had to be intubated and received a blood transfusion.The patient is in good condition post-procedure.During the pre-deco evaluation of the devices sent back for return, the valve was received crimped and multiple bent struts on the valve were bent at the outwards and inwards outflow aspect with multiple struts exposed into the skirt.

Manufacturer Narrative

The investigation is ongoing.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2023-10553.

Manufacturer Narrative

Correction to h6; type of investigation, investigation findings, investigation conclusion.Update to h2 and h3.The 23mm sapien 3 ultra valve was returned for examination.The visual examination found that the valve was crimped on the inflation balloon and multiple struts were bent (outwards and inwards) at the outflow side.Dimensional and functional testing were not able to be performed.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformances that would have contributed to the complaint event.A lot history review was performed and revealed no other complaints relating to the complaint.The following instructions for use (ifu) were reviewed: commander delivery system with s3/s3u, device preparation training manual, and procedural training manual.Based on this review, no ifu/training deficiencies were identified.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.During manufacturing, all sapien 3 ultra valve assemblies undergo the following inspections: the in-process sapien 3 universal valves are 100% visually inspected for valve od (outer diameter) with go/no-go ring gauge during manufacturing.During the final assembly, the sapien 3 ultra valves are 100% visually inspected before and after holder attachment during manufacturing.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.The complaint for frame damage was confirmed based on provided imagery and 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 withdrawal of the devices, the esheath was pulled out completely and the catheter with the valve stayed in the patient and a surgical cutdown was performed".Per returned device evaluation, multiple valve struts were bent outward/inward on outflow.In this case, it is possible that the struts got caught on the sheath during the valve/ds system retrieval and sustained damage/deformation if excessive device manipulation was used to overcome the resulting resistance.Available information suggests that procedural factors (excessive device manipulation, withdrawal of crimped valve) may have contributed to the 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.

• 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: 16293998
• MDR Text Key: 308748749
• Report Number: 2015691-2023-10556
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750TFX23
• Device Catalogue Number: 9750TFX23A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2022
• 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
• Patient Age: 91 YR
• Patient Sex: Male