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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  malfunction  

Event Description

As reported, it was a case of an implant of a 23mm sapien 3 ultra valve.During esheath insertion, the 14fr esheath could not pass a kinking area and had to be retrieved.After the withdrawal, it was noticed that the distal tip of the esheath was split.To continue the procedure, a new 14fr esheath was inserted.However, the new esheath was perforated by the commander delivery system when it was advanced through the esheath.The perceived root cause of this event was presumably a kinking area.As per pre-decontamination observations, sheath shaft puncture and one frame strut bent outwards at inflow side were observed.

Manufacturer Narrative

Reference no.(b)(4).The investigation is ongoing.

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 returned to edwards lifesciences for evaluation and the following was observed.Valve was found crimped at distal part of balloon and exposed through torn liner and one frame strut bent outwards at inflow side.Imagery was provided from the site and revealed the following: crimped valve exposed through liner puncture and calcification present at access vessel.Access vessel with tortuous anatomy.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 evaluation of the returned device.Available information suggests that patient factors (calcification, tortuosity) and procedural factors (excessive manipulation) likely contributed to the event, per 3mensio provided, calcification and tortuosity were present in patient's access vessels.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
• MDR Report Key: 18485270
• MDR Text Key: 332565596
• Report Number: 2015691-2024-00247
• 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: 03/18/2024

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: 9750TFX23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2023
• 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: 85 YR