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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.H3 other text : the device has not been returned.

Event Description

As reported, it was a case of an implant of a 26mm sapien 3 ultra, in aortic position by transfemoral approach.There was no abnormality was detected in esheath or delivery system prior to insertion.The esheath was inserted at a steep angle and the vessel was pre-dilated with a 14fr dilator.When the commander delivery system was being inserted through esheath, the delivery system got stuck in the non-expandable area of esheath and a bent strut was noticed by fluoroscopy.It was decided to withdraw all the system from the patient as one unit.There was no patient injury.A new system was prepared, and the procedure was successfully performed.The patient final outcome was good.As per medical opinion, the perceived root cause of this event might have been an user error.

Manufacturer Narrative

This is one of three manufacturer reports being submitted for this case.Reference related manufacturer report no: 2015691-2023-18267 and 2015691-2023-18268.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected d.9 date returned to manufacturer, h.3 device evaluated by manufacturer, h.6 component codes and investigation conclusions and investigation findings.Added new information to h.6 type of investigation.The device was returned to edwards lifesciences for evaluation and the following was observed.Sapien 3 ultra valve received stuck inside esheath.One strut bent outwards at inflow side.Leaflets wrinkled and dehydrated due to storage condition (prolonged crimping) during the return handling process.Imagery was provided from the site and revealed the following: sheath strain relief damaged.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaint was confirmed based on the evaluation of the returned device.Available information suggests that patient factors (calcification, tortuosity) and procedural factors (steep insertion angle, high push force) likely contributed to the event.As per follow up with field clinical specialist (fcs), the degree of calcification and tortuosity in patient's access vessel was mild and moderate, respectively.Additionally, the description states that ''the esheath was inserted at a steep angle''.Calcification can reduce the vessel lumen diameter and may increase restriction leading to resistance.Calcification can also result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.Scratches observed on the sheath shaft can be indicative of the presence of calcified nodules within the access vessel.Tortuous patient anatomy can create sub-optimal angles that can lead to non-coaxial alignment between the delivery system with crimped valve and sheath inner lumen.Kinks or curvature along the sheath shaft can be indicative of the presence of vessel tortuosity.Moreover, a steep insertion angle can result in non-coaxial alignment between the delivery system and sheath.Non-coaxial advancement of the delivery system through the sheath may lead to resistance.Finally, excessive device manipulation or high push force can lead to the valve struts interacting with the sheath shaft and result in the strut damage at the valve inflow side.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: 18125799
• MDR Text Key: 328630389
• Report Number: 2015691-2023-17465
• 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,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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750TFX26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 12/11/2023; 01/11/2024
• Supplement Dates FDA Received: 12/11/2023; 01/12/2024
• 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