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

Model Number 9750TFX26A

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.H3 other text : not returned for evaluation.

Event Description

As reported by the field clinical specialist, during a right transfemoral tavr procedure, a 26 mm sapien 3 ultra valve was prepped and inserted into the 14f esheath.Extreme push force was noted by the physician who was unable to advance the valve.The patient had tortuous anatomy.Fluoro showed the valve stuck in the non-expandable portion of the esheath with one of the struts beginning to bend outward on the crimped valve.The esheath and 26 mm commander delivery system were removed, and a new sheath and valve system was prepped and delivered without injury to the patient.No patient complications were reported.Per follow up from the clinical specialist, there were no abnormalities noted with the sheath during prep.The loader was able to be fully inserted into the sheath/sheath housing.The sheath was not inserted at a steep angle.The vessel pre-dilated up to 16f.The gray area of the sheath was perforated slightly with the valve frame.

Manufacturer Narrative

A supplemental report is being submitted for the completed engineering evaluation.Sections b.2, b.4, g.3, g.6, and h.2 have been updated.Corrections have been made to h.6: component code, type of investigation, investigation findings, and investigation conclusion.The event reported is anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.An additional assessment of the failure mode is not required at this time.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.An existing technical summary written by edwards lifesciences establishes, through extensive complaint investigations, that events reporting resistance during delivery system insertion/advancement through the sheath and potential valve frame damage using the sapien 3 ultra/sapien 3 ultra resilia valve configuration have not been associated with device malfunctions or manufacturing nonconformances.Rather, the root cause for these events have been due to vessel tortuosity, calcification, undersized vessels, and/or a steep insertion angle.In addition, valve frame and/or sheath damage can be a result of increased push force and any excessive device manipulation or sheath-valve interaction.Therefore, it is likely that these patient/procedural factors may have caused or contributed to the difficulty advancing the delivery system through the sheath and valve frame and/or sheath damage.Per the technical summary, the instructions for use (ifu), current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The complaint for frame damage was unable to be confirmed based on no device or imagery returned.Available information suggests tortuosity and high push force likely contributed to the event as tortuosity was reported in the patient anatomy and high push force was reported during valve insertion through the sheath.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.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 on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18379090
• MDR Text Key: 331189014
• Report Number: 2015691-2023-18704
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)260516
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

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: 9750TFX26A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• 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 Sex: Male