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 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, it was a case of a 26mm sapien 3 ultra transcatheter heart valve, in aortic position by transfemoral approach.During procedure, the system was forced into the esheath+.When advancing through the aorta with the valve, it was noted that one valve strut bent.It was decided to not implant the valve.The valve was retrieved inside the esheath+ and the system was removed as one unit.A second valve was prepared and used with a 16fr sheath.The procedure went well.There was no esheath+ damage noted and no patient injury.As per medical opinion, it was due to an error in crimping or excessive push force at the beginning.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 component codes and investigation conclusions and investigation findings.Added new information to h.6 type of investigation.The device was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was provided from the site and revealed the following: bent frame strut visible on crimped valve while crossing aortic arch.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 provided imagery.Available information suggests that patient factors (calcification, tortuosity) and procedural factors (excessive manipulation) likely contributed to the event as the patient presented mild vessel calcification and mild tortuosity.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.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, especially if compounded with vessel tortuosity.Excessive device manipulation or high push force can lead to the valve struts interacting with the sheath shaft and/or liner, resulting in the frame 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: 18767807
• MDR Text Key: 336115340
• Report Number: 2015691-2024-01267
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• 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 Age: 83 YR
• Patient Sex: Male