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 Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Vascular Dissection (3160)

Event Date 10/25/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported from finland by our edwards lifesciences affiliate, during a transfemoral transcatheter aortic valve procedure with a 26mm sapien 3 ultra valve, the valve and 26mm commander delivery system became stuck when advanced through the 14fr esheath.The devices were withdrawn as a unit.During withdrawal, an injury at the iliac artery occurred.The injury was treated with an endovascular stent prosthesis and hemostasis was achieved.Upon removal of the ew devices, the valve frame was damaged, and the esheath liner was punctured, torn, and had strands.The devices were exchanged, and the procedure successfully concluded.The patient lost 1.5 liters of blood, and hemoglobin dropped to 80 g/l.The bleeding led to a large hematoma, which became infected.The patient stayed at the hospital 7 days post-procedure but was discharged in good condition.

Manufacturer Narrative

This is one of two reports being submitted for this case.Please reference related manufacturer report no.: 2015691202317532.Investigation is ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information based on the device evaluation.The following sections of this report have been updated: corrected h6 component code, additional codes added to h6 type of investigation, corrected h6 investigation findings, corrected h6 investigation conclusions.The device was returned to edwards lifesciences for evaluation.The returned device was visually examined, and the following was observed: two (2) frame struts bent outwards on the outflow side.Due to the nature of the event, no functional or dimensional testing was performed.Imagery was provided and the following was observed: crimped valve inflow side puncture through sheath observed during procedure, crimped valve exposed through esheath with frame struts bent outwards at outflow side post-procedure.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A review of the lot history revealed no other similar returned complaints for the trend categories.The instructions for use/training manuals were reviewed for guidance/instruction involving the valve usage.Based on the review of the ifu/training manuals, no deficiencies were identified.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 valve frame damage was confirmed based on provided imagery and returned device.Per training manual, "push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification." calcification can reduce the vessel diameter and may increase restriction leading to resistance.Calcification can result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.Excessive device manipulation and/or high push and pull force can lead to the valve struts interacting with the sheath shaft and resulted the strut damage at the valve outflow side.Based on available information, investigation suggests that patient factors (calcification) and/or procedural factors (excessive device manipulation, withdrawal of crimped valve) may have contributed to the reported 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.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• 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: 18145615
• MDR Text Key: 328224442
• Report Number: 2015691-2023-17530
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750TFX26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 11/16/2023; 01/11/2024
• Supplement Dates FDA Received: 11/17/2023; 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2023
• 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): Hospitalization; Required Intervention; Life Threatening